i

Manufacturer
FUJIFILM SonoSite, Inc.
21919 30th Drive SE
Bothell, WA 98021-3904
USA
Telephone: 1-888-482-9449 or 1-425-951-1200
Fax: 1-425-951-1201

EC Authorized Representative
FujiFilm SonoSite B.V.
Joop Geesinkweg 140
1114 AB Amsterdam, The Netherlands

Australia Sponsor
FUJIFILM SonoSite Australasia Pty Ltd
114 Old Pittwater Rd
Brookvale, New South Wales 2100, Australia

Caution: Federal (United States) law restricts this device to sale by or on the order of a physician.

Edge, SiteLink, SonoCalc, SonoHD2, SonoMB, SonoMBe, SonoSite, and the SonoSite logo are registered (in some jurisdictions) and
unregistered trademarks owned by FUJIFILM SonoSite, Inc.

DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital
communications of medical information.

Non-SonoSite product names may be trademarks or registered trademarks of their respective owners.

The SonoSite ultrasound system(s) referenced in this document may be covered by one or more of the following U.S. patents:
Patents: US 8,439,840; US 8,398,408; US 8,355,554; US 8,216,146; US 8,213,467; US 8,147,408; US 8,137,278; US 8,088,071; US 8,066,642;
US 8,052,606; US 7,819,807; US 7,804,970; US 7,740,586; US 7,686,766; US 7,604,596; US 7,591,786; US 7,588,541; US 7,534,211; US
7,449,640; US 7,169,108; US 6,962,566; US 6,648,826; US 6,575,908; US 6,569,101; US 6,471,651; US 6,416,475; US 6,383,139; US
6,364,839; US 6,203,498; US 6,135,961; US 5,893,363 ; US 5,817,024; US 5,782,769; US 5,722,412; US 8,805,047; US 8,527,033; US
8,858,436; US 8,861,822; US 8,956,296; AU: 730822; AU: 727381; CA 2,372,152; CA: 2,371,711; CN 98108973.9; CN 98106133.8; CN
97113678.5; DE 69831698.3; DE 69830539.6; DE 69730563.5; DE 602004027882.3; DE 602004023816.3; DE: 60034670.6; DE 60029777.2;
EP 1589878; EP 1552792; EP 1180971; EP 0875203; EP 0815793; EP 1180970; EP 0881492; ES 2229318; ES 159878; ES 1552792; ES
0881492; FR 158978; FR 1552792; FR 1180970; FR 0881492; FR 0875203; FR 0815793; GB 158978; GB 1552792; GB 1180971; GB 1180970;
GB 0881492; GB 0875203; GB 0815793; IT 1589878; IT 1552792; IT 0881492; IT 0815793; JP 4696150; KR 532359; KR 528102; NO 326814;
NO 326202 and pending.

P21828-02 10/2018
Copyright © 2018 FUJIFILM SonoSite, Inc.
All rights reserved.

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iii
iv
Introduction.........................................................................1
Audience ..............................................................................................1
Contact Information ..............................................................................1
Conventions, symbols, and terms ........................................................2
Labeling symbols..................................................................................2
Specifications .....................................................................7
Specifications .......................................................................................7
Dimensions...........................................................................................7
System .................................................................................................7
Display..................................................................................................7
Environmental limits .............................................................................7
Operating (system, battery, and transducer)........................................7
Shipping and storage (system and transducer)....................................7
Shipping and storage (battery) .............................................................7
Electrical specifications ........................................................................7
Battery specifications ...........................................................................8
Compatible accessories and peripherals .............................................8
Safety...................................................................................11
Electrical safety ....................................................................................11
Electrical safety classification...............................................................13
Equipment safety..................................................................................13
Battery safety .......................................................................................14
Clinical safety .......................................................................................15
Hazardous materials ............................................................................15
Electromagnetic compatibility...............................................................16
Electrostatic discharge .........................................................................16
Separation distance..............................................................................17
Guidance and manufacturer’s declaration............................................18
Immunity testing requirements .............................................................21
Standards .............................................................................................21
Electrical safety standards ...................................................................21
EMC standards classification ...............................................................21
Acoustic standards ...............................................................................21
Biocompatibility standards....................................................................21
Airborne equipment standards .............................................................22
DICOM standard ..................................................................................22
HIPAA standard....................................................................................22
System Overview................................................................23
About the System .................................................................................23
Theory of Operation .............................................................................24
Description of Operating Modes...........................................................25
Additional System Feature Performances............................................27
Front End Overview..............................................................................28
PW Doppler Processing .......................................................................30
CW Doppler Processing .......................................................................31
Back End Overview ..............................................................................32
Control Subsystem ...............................................................................33
Power Supply and Control....................................................................34

v
ECG Module.........................................................................................36
DICOM .................................................................................................37
Troubleshooting .................................................................39
System and Subsystem Diagnosis.......................................................39
System Repair......................................................................................40
Test Equipment ....................................................................................40
Failure (Assert) Codes .........................................................................40
Verifying a System Assert Code...........................................................40
DICOM .................................................................................................42
Display..................................................................................................43
Battery ..................................................................................................43
Control Panel........................................................................................43
Replacement Procedures ..................................................45
Display Replacement ...........................................................................45
Required Parts .....................................................................................45
Required Tools .....................................................................................45
Display Removal ..................................................................................45
Display Replacement ...........................................................................49
Test the Display....................................................................................49
Control Panel Subassembly Replacement...........................................49
Required Parts .....................................................................................50
Required Tools .....................................................................................50
Control Panel Removal ........................................................................51
Control Panel Replacement .................................................................51
TGC Assembly Removal ......................................................................51
Main System Disassembly for Repair and/or Replacement .................52
Required Parts .....................................................................................52
Required Tools .....................................................................................52
System Disassembly ............................................................................53
Speaker Replacement..........................................................................53
Required Part .......................................................................................53
Power Supply PCBA Replacement ......................................................55
Required Part .......................................................................................55
SD Card Replacement .........................................................................56
USB Extension PCB Assembly Replacement ......................................56
Required Part .......................................................................................56
Main PCBA Replacement.....................................................................56
Required Parts .....................................................................................56
Midframe Replacement ........................................................................59
Required Parts .....................................................................................59
Bottom Enclosure Replacement...........................................................60
Required Parts .....................................................................................60
Maintenance........................................................................61
Periodic Maintenance...........................................................................61
Performance Testing..........................................................63
Overview ..............................................................................................63
Recommend Test Equipment...............................................................63
Setting Up Performance Tests .............................................................63

vi
Basic Operational Tests .......................................................................64
2D Performance Tests .........................................................................64
2D Performance / Image Quality ..........................................................64
Axial Measurement Accuracy...............................................................65
Lateral Measurement Accuracy............................................................65
Penetration ...........................................................................................66
Additional Performance Tests ..............................................................66
Color Doppler (Color) ...........................................................................66
Color Power Doppler (CPD) .................................................................67
M Mode Imaging...................................................................................67
Tissue Harmonic Imaging.....................................................................67
Image Quality Verification Test/Livescan .............................................67
Printer...................................................................................................68
Battery Charging ..................................................................................68
Video Output ........................................................................................68
Replacement Parts .............................................................69
Replacement Parts...............................................................................69
Display..................................................................................................69
Control Panel........................................................................................70
Main PCBA...........................................................................................71
Miscellaneous Parts .............................................................................73
Transducer Nest Frame Assembly.......................................................77
Ordering Replacement Parts................................................................78
Service Event Reporting ....................................................79
Service Event Report Form ..................................................................80
Service Event Report Instructions ........................................................81
Returning Products to SonoSite ...........................................................82
Shipping Instructions ............................................................................82

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Chapter 1: Introduction

Before servicing the SonoSite Edge II Ultrasound System, please read this manual.
The ultrasound system has multiple configurations and feature sets. All are described in this service manual
but not every option may apply to your system. System features depend on your system configuration,
transducer, and exam type.
Refer to the SonoSite Edge II Ultrasound System User Guide for additional information regarding safety,
system controls, operation, capabilities, and specifications.
This chapter also defines labeling symbols, specifications, and standards.

Audience
The intended audience of this manual is properly trained field and in-house service personnel.

Contact Information
Questions and comments are encouraged. SonoSite is interested in your feedback regarding the service
manual. If you encounter difficulty with the system, use the information in this manual to help correct the
problem. If the problem is not covered here, contact SonoSite Technical Support as follows:

Technical Support (USA, Canada) 1-877-657-8118

Technical Support fax: 1-425-951-6700

Technical Support e-mail: [email protected]

SonoSite website: www.sonosite.com

International Technical Support: Contact your local representative or call (USA) +425-951-1330

European Service Center United Kingdom

Tel: 0044 01462341151
e-mail: [email protected]

France
Tel: 0033 01/82880702
e-mail: [email protected]

Germany
Tel: 0049 069/80884030
e-mail: [email protected]

Spain
Tel: 0034 911238451
e-mail: [email protected]

Italy
Tel 0039 02 94753655
e-mail: [email protected]

Asia/Pacific Tel: (+65) 63805581

e-mail: [email protected]

Chapter 1: Introduction 1
Conventions, symbols, and terms
The user guide follows these conventions:
• A WARNING describes precautions necessary to prevent injury or loss of life.
• A Caution describes precautions necessary to protect the products.
• Numbered steps in procedures must be performed in order.
• Items in bulleted lists do not require performance in sequence.

Labeling symbols
The following symbols are used on the products, packaging, and containers.
Table 1: Labeling Symbols

Symbol Definition
Alternating Current (AC)

Class 1 device indicating manufacturer’s declaration of conformance with

Annex VII of 93/42/EEC

Class 1 device requiring verification by the Notified Body of sterilization or

measurement features, or to a Class IIa, IIb, or III device requiring
verification or auditing by the Notified Body to applicable Annex(es) of
93/42/EEC
Attention, see the user guide

Follow instructions for use.

Device complies with relevant Australian regulations for electronic devices.

Batch code, date code, or lot code type of control number

LOT
Biological risk

Device complies with relevant Brazilian regulations for electro-medical

devices.

Canadian Standards Association. The “C” and “US” indicators next to this
mark signify that the product has been evaluated to the applicable CSA
and ANSI/UL Standards, for use in Canada and the US, respectively.

REF Catalog number

Collect separately from other household waste (see European Commission

Directive 93/86/EEC). Refer to local regulations for disposal.

2 Chapter 1: Introduction
Table 1: Labeling Symbols (Continued)

Symbol Definition
Corrugated recycle

Dangerous voltage

Date of manufacture

Manufacturer

Direct Current (DC)

Do not get wet.

Do not stack over 2 high.

Do not stack over 5 high.

Do not stack over 10 high.

Electrostatic sensitive devices

Device complies with relevant FCC regulations for electronic devices.

Fragile

GEL Gel

Sterilized using irradiation

STERILE R

STERILE EO Sterilized using ethylene oxide

Hot

Chapter 1: Introduction 3
 Table 1: Labeling Symbols (Continued)

Symbol Definition
Device emits a static (DC) magnetic field.

Non-ionizing radiation

Paper recycle

SN Serial number type of control number

Temperature limitation

Atmospheric pressure limitation

Humidity limitation

Submersible. Protected against the effects of temporary immersion.

Water-Tight Equipment. Protected against the effects of extended

immersion.
Handle transducer with care.

Follow manufacturer’s instructions for disinfecting time.

Disinfect transducer.

Type BF patient applied part

(B = body, F = floating applied part)

Defibrillator proof type CF patient applied part

Underwriter’s Laboratories labeling

Pollution Control Logo. (Applies to all parts/products listed in the China

RoHS disclosure table. May not appear on the exterior of some
parts/products because of space limitations.)

China Compulsory Certificate mark (“CCC Mark”). A compulsory safety

mark for compliance to Chinese national standards for many products sold
in the People’s Republic of China.

4 Chapter 1: Introduction
Table 1: Labeling Symbols (Continued)

Symbol Definition
WARNING: WARNING: Connect Only Accessories and Peripherals Recommended by
Connect Only FujiFilm SonoSite
Accessories and
Peripherals
Recommended
by FujiFilm
SonoSite

Chapter 1: Introduction 5
6 Chapter 1: Introduction
Chapter 2: Specifications

This chapter contains information regarding system specifications and accessory compatibility. The
information applies to the ultrasound system, transducers, accessories, and peripherals.

Specifications
Dimensions
System
• Length: 13 in. (33 cm)
• Width: 12.4 in. (31.5 cm)
• Height: 2.5 in. (6.3 cm)

Display
• Length: 9.7 in. (24.6 cm)
• Height: 7.3 in. (18.5 cm)
• Diagonal: 12.1 in. (30.7 cm)

Environmental limits
Note: The temperature, pressure, and humidity limits apply only to the ultrasound system, transducers,
and battery.

Operating (system, battery, and transducer)

10–40°C (50–104°F), 15–95% R.H.
700 to 1060hPa (0.7 to 1.05 ATM)
Mode of Operation:
Continuous 35°C or below
Non-Continuous above 35°C (30 minutes on /30 minutes off)

Shipping and storage (system and transducer)

-35–65°C (-31–149°F), 15–95% R.H.
500 to 1060hPa (0.5 to 1.05 ATM)

Shipping and storage (battery)

-20–60°C (-4–140°F), 15–95% R.H. (For storage longer than 30 days, store at or below room temperature.)
500 to 1060hPa (0.5 to 1.05 ATM)

Electrical specifications
Power Supply Input: 100-240 VAC, 50/60 Hz, 2.0 A Max @ 100 VAC
Power Supply Output #1: 15 VDC, 5.0 A Max
Power Supply Output #2: 12 VDC, 2.3 A Max
Combined output not exceeding 75 watts.

Chapter 2: Specifications 7
 Battery specifications
The battery is comprised of six lithium-ion cells plus electronics, a temperature sensor, and battery contacts.
Run time is up to two hours, depending on imaging mode and display brightness.

Compatible accessories and peripherals

SonoSite has tested the SonoSite Edge II ultrasound system with the following accessories and peripherals
and has demonstrated compliance to the requirements of IEC60601-1-2:2007.
You may use these SonoSite accessories and third-party peripherals with the SonoSite Edge II ultrasound
system.

WARNING: Use of the accessories with medical systems other than the SonoSite
Edge II ultrasound system may result in increased emissions or decreased
immunity of the medical system.
WARNING: Use of accessories other than those specified may result in increased
emissions or decreased immunity of the ultrasound system.

Accessories and peripherals compatible with SonoSite Edge II ultrasound system

Description Part Number Maximum Cable Length

C8x transducer P08010 6.0 ft/1.8 m

C11x transducer P07678 6.5 ft/2.0 m

C35x transducer P21981 6.0 ft/1.8 m

rC60xi transducer P21070 5.5 ft/1.7 m

rC60xi transducer armored P21636 5.5 ft/1.7 m

rP19x transducer P21015 6.0 ft/1.8 m

rP19x transducer armored P21556 6.0 ft/1.8 m

HFL38xi transducer P20311 5.5 ft/ 1.7 m

HFL38xi transducer armored P20377 5.5 ft/1.7 m

HFL50x transducer P07693 6.0 ft/1.8 m

HSL25x P20679 7.5 ft/2.3 m

ICTx transducer P07690 6.0 ft/1.8 m

L25x transducer P07691 7.5 ft/2.3 m

L25x transducer armored P22950 7.5 ft/2.3 m

L38xi transducer P12742 6.0 ft/1.8 m

L38xi transducer armored P19626 6.0 ft/1.8 m

L52x transducer (Vet) V00033 7.5 ft/2.3 m

L52x transducer armored (Vet) V20962 7.5 ft/2.3 m

P10x transducer P07696 6.5 ft/2.0 m

TEExi transducer P19825 7.5 ft/2.3 m

8 Chapter 2: Specifications
Accessories and peripherals compatible with SonoSite Edge II ultrasound system (Continued)

Bar code scanner P14166 4.8 ft/1.5 m

Kit, PowerPack P13559 —

Black & white printer P13745 —

Hybrid black & white printer P20006

Black & white printer power — 3.3 ft/1 m

cable

Black & white printer USB — 10.8 ft/3.3 m

cable

Color printer P13983 —

Color printer power cable — 3.3 ft/1 m

Color printer video cable — 6.0 ft/ 1.8 m

ECG lead wires P14202 24 in/ 0.6 m

ECG module P08501 5.8 ft/1.8 m

Edge Mini-Dock P15078 —

Edge Stand P15800 —

Dual USB Footswitch P14689 9.8 ft/3.0 m

Power cord (system) P00848 (USA) 10 ft/3 m

Power Supply/Battery Charger P09823 6.8 ft/ 2 m

PowerPark P12822 —

Storage bin kit, Universal/Edge P22048

stands

Triple Transducer Connect P16535 —

USB wireless adapter P17725 —

EU compliant wireless adapter P22625

Edge Battery Pack P15051 —

Wireless mounting kit P17724

Chapter 2: Specifications 9
10 Chapter 2: Specifications
Chapter 3: Safety

This chapter contains electrical and clinical safety information required by regulatory agencies. The
information applies to the ultrasound system, transducers, accessories, and peripherals.

Electrical safety
This system meets EN60601-1, Class I/internally-powered equipment requirements and Type BF and Type
CF isolated patient-applied parts safety requirements.
This system complies with the applicable medical equipment requirements published in the Canadian
Standards Association (CSA), European Norm Harmonized Standards, and Underwriters Laboratories (UL)
safety standards. See “Standards” on page 21.
For maximum safety observe the following warnings and cautions.

WARNING: To avoid the risk of injury, do not operate the system in the presence of
flammable gasses or anesthetics. Explosion can result.
WARNING: To avoid the risk of electrical shock or injury, do not open the system
enclosures. All internal adjustments and replacements, except battery
replacement, must be made by a qualified technician.
WARNING: To avoid the risk of electrical shock:
• This equipment must be connected only to a supply mains with protective
earth.
• Use only properly grounded equipment. Shock hazards exist if the power
supply is not properly grounded. Grounding reliability can be achieved only
when equipment is connected to a receptacle marked “Hospital Only” or
“Hospital Grade” or equivalent. The grounding wire must not be removed or
defeated.
• When using the system in an environment where the integrity of the protective
earth conductor arrangement is in doubt, operate the system on battery
power only and disconnect the power supply.
• Do not let the bar code scanner or external mouse touch the patient.
• Do not touch any of the following:
• The power supply and the patient at the same time
• The ungrounded signal input/output connectors on the back of the
ultrasound system
• The system battery contacts (inside the battery compartment)
• The system transducer connector when the transducer or Triple
Transducer Connect (TTC) is disconnected
• The system transducer connector on the TTC if no transducers are
connected

Chapter 3: Safety 11
 • Do not connect the system power supply or docking system to a multiple
portable socket outlet (MPSO) or extension cord.
• Before using the transducer, inspect the transducer face, housing, and cable.
Do not use the transducer if the transducer or cable is damaged.
• Always disconnect the power supply from the system before cleaning the
system.
• Do not use any transducer that has been immersed beyond the specified
cleaning or disinfection level. See Chapter 7, “Maintenance”.
• Use only accessories and peripherals recommended by SonoSite, including
the power supply. Connection of accessories and peripherals not
recommended by SonoSite could result in electrical shock. Contact SonoSite
or your local representative for a list of accessories and peripherals available
from or recommended by SonoSite.
WARNING: To avoid the risk of electrical shock and fire hazard:
• Inspect the power supply, AC power cords, cables, and plugs on a regular
basis. Ensure that they are not damaged.
• The power cord set that connects the power supply of the ultrasound system
or the stand to mains power must only be used with the power supply or
docking system, and cannot be used to connect other devices to mains
power.
WARNING: To prevent injury to the operator/bystander, the transducer must be removed
from patient contact before the application of a high-voltage defibrillation pulse.
WARNING: To avoid possible electrical shock or electromagnetic interference, verify proper
operation and compliance with relevant safety standards for all equipment
before clinical use. Connecting additional equipment to the ultrasound system
constitutes configuring a medical system. SonoSite recommends verifying that
the system, all combinations of equipment, and accessories connected to the
ultrasound system comply with JACHO installation requirements and/or safety
standards such as AAMI-ES1, NFPA 99 OR IEC Standard 60601-1-1 and
electromagnetic compatibility standard IEC 60601-1-2 (Electromagnetic
compatibility), and are certified according to IEC Standard 60950 (Information
Technology Equipment (ITE)).

Caution: Do not use the system if an error message appears on the LCD display. Note
the error code and call SonoSite Technical Support for further assistance.
Caution: To avoid increasing the system and transducer connector temperature, do not
block the airflow to the ventilation holes on the side of the system.

12 Chapter 3: Safety
Electrical safety classification

Class I equipment The ultrasound system is classified as Class I equipment

when powered from the external power supply or mounted
on the stand because the external power supply is a Class
1 protectively earthed power supply.
The stand has no protective earth. Ground bond testing is
not applicable to the ultrasound system or the stand.
Note:AC powered peripherals that may be used with the system
are Class I and are individually protectively earthed. Ground bond
testing may be conducted on each AC powered peripheral.

Internally powered Ultrasound system not connected to the power supply

equipment (battery only)

Type BF applied parts Ultrasound transducers

Type CF applied parts ECG module/ECG leads

IPX-7 (watertight Ultrasound transducers

equipment)

IPX-8 (watertight Footswitch

equipment)

Non AP/APG Ultrasound system power supply, docking system, and

peripherals. Equipment is not suitable for use in the
presence of flammable anaesthetics.

Equipment safety
To protect your ultrasound system, transducers, and accessories, follow these precautions.

Caution: Excessive bending or twisting of cables can cause a failure or intermittent

operation.
Caution: Improper cleaning or disinfecting of any part of the system can cause
permanent damage. For cleaning and disinfecting instructions, see Chapter 7,
“Maintenance”.
Caution: Do not submerge the transducer connector in solution. The cable is not
liquid-tight beyond the transducer connector/cable interface.
Caution: Do not use solvents such as thinner or benzene, or abrasive cleaners on any
part of the system.
Caution: Remove the battery from the system if the system is not likely to be used for a
month or more.
Caution: Do not spill liquid on the system.

Chapter 3: Safety 13
 Battery safety
To prevent the battery from bursting, igniting, or emitting fumes and causing personal injury or equipment
damage, observe the following precautions.

WARNING: The battery has a safety device. Do not disassemble or alter the battery.
WARNING: Charge the batteries only when the ambient temperature is between 0° and
40°C (32° and 104°F).
WARNING: Do not short-circuit the battery by directly connecting the positive and negative
terminals with metal objects.
WARNING: Do not touch battery contacts.
WARNING: Do not heat the battery or discard it in a fire.
WARNING: Do not expose the battery to temperatures over 60°C (140°F). Keep it away
from fire and other heat sources.
WARNING: Do not charge the battery near a heat source, such as a fire or heater.
WARNING: Do not leave the battery in direct sunlight.
WARNING: Do not pierce the battery with a sharp object, hit it, or step on it.
WARNING: Do not use a damaged battery.
WARNING: Do not solder a battery.
WARNING: The polarity of the battery terminals isfixed and cannot be switched or
reversed. Do not force the battery into the system.
WARNING: Do not connect the battery to an electrical power outlet.
WARNING: Do not continue recharging the battery if it does not recharge after two
successive six hour charging cycles.
WARNING: Do not ship a damaged battery without instructions from SonoSite Technical
Support. (See “Technical Support (USA, Canada)” on page 1.)
WARNING: If the battery leaks or emits an odor, remove it from all possible flammable
sources.
WARNING: Periodically check to make sure that the battery charges fully. If the battery fails
to charge fully, replace it.

Caution: To avoid the battery becoming damaged and causing equipment damage,
observe the following precautions:
• Do not immerse the battery in water or allow it to get wet.
• Do not put the battery into a microwave oven or pressurized container.
• If the battery emits an odor or heat, is deformed or discolored, or in any way
appears abnormal during use, recharging or storage, immediately remove it
and stop using it. If you have any questions about the battery, consult SonoSite
or your local representative.
• Store the battery between -20°C (-4°F) and 60°C (140°F).
• Use only SonoSite batteries.
• Do not use or charge the battery with non-SonoSite equipment. Only charge
the battery with the system.

14 Chapter 3: Safety
Clinical safety
WARNING: Non-medical (commercial) grade peripheral monitors have not been verified or
validated by SonoSite as being suitable for diagnosis.
WARNING: To avoid the risk of a burn hazard, do not use the transducer with high
frequency surgical equipment. Such a hazard may occur in the event of a
defect in the high frequency surgical neutral electrode connection.
WARNING: Do not use the system if it exhibits erratic or inconsistent behavior.
Discontinuities in the scanning sequence are indicative of a hardware failure
that must be corrected before use.
WARNING: Some transducer sheaths contain natural rubber latex and talc, which can
cause allergic reactions in some individuals. Refer to 21 CFR 801.437, User
labeling for devices that contain natural rubber.
WARNING: Perform ultrasound procedures prudently. Use the ALARA (as low as
reasonably achievable) principle and follow the prudent use information
concerning MI and TI.
WARNING: SonoSite does not currently recommend a specific brand of acoustic standoff. If
an acoustic standoff is used, it must have a minimum attenuation
of .3dB/cm/MHz.
WARNING: Some SonoSite transducers are approved for intraoperative applications if a
market-cleared sheath is used.
WARNING: To avoid injury and reduce risk of infection to the patient, observe the following:
• Follow Universal Precautions when inserting and maintaining a medical
device for interventional and intraoperative procedures.
• Appropriate training in interventional and intraoperative procedures as
dictated by current relevant medical practices as well as in proper operation
of the ultrasound system and transducer is required. During vascular access,
the potential exists for serious complications including without limitation the
following: pneumothorax, arterial puncture, guidewire misplacement, and
risks normally associated with local or general anesthesia, surgery, and
post-operative recovery.
WARNING: To avoid device damage or patient injury, do not use the P10x or P21x needle
guide bracket on patients with pacemakers or medical electronic implants. The
needle guide bracket for the P10x and P21x transducers contains a magnet
that is used to ensure the bracket is correctly oriented on the transducer. The
magnetic field in direct proximity to the pacemaker or medical electronic
implant may have an adverse effect.

Hazardous materials
WARNING: Products and accessories may contain hazardous materials. Ensure that
products and accessories are disposed of in an environmentally responsible
manner and meet federal and local regulations for disposing hazardous
materials.

Chapter 3: Safety 15
 Electromagnetic compatibility
The ultrasound system has been tested and found to comply with the electromagnetic compatibility (EMC)
limits for medical devices to IEC 60601-1-2:2001. These limits are designed to provide reasonable
protection against harmful interference in a typical medical installation.

WARNING: The Sonosite Edge II ultrasound system should not be used adjacent to or
stacked with other equipment. If such use occurs, verify that the SonoSite Edge
II ultrasound system operates normally in that configuration.
Caution: Medical electrical equipment requires special precautions regarding EMC and
must be installed and operated according to these instructions. Portable and
mobile RF communications equipment can affect the ultrasound system.
Electromagnetic interference (EMI) from other equipment or interference
sources could result in performance disruption of the ultrasound system.
Evidence of disruption may include image degradation or distortion, erratic
readings, equipment ceasing to operate, or other incorrect functioning. If this
occurs, survey the site to determine the source of disruption, and take the
following actions to eliminate the source(s).
• Turn equipment in the vicinity off and on to isolate disruptive equipment.
• Relocate or re-orient interfering equipment.
• Increase distance between interfering equipment and your ultrasound
system.
• Manage use of frequencies close to ultrasound system frequencies.
• Remove devices that are highly susceptible to EMI.
• Lower power from internal sources within facility control (such as paging
systems).
• Label devices susceptible to EMI.
• Educate clinical staff to recognize potential EMI-related problems.
• Eliminate or reduce EMI with technical solutions (such as shielding).
• Restrict use of personal communicators (cell phones, computers) in areas
with devices susceptible to EMI.
• Share relevant EMI information with others, particularly when evaluating new
equipment purchases which may generate EMI.
• Purchase medical devices that comply with IEC 60601-1-2 EMC Standards.
Caution: To avoid the risk of increased electromagnetic emissions or decreased
immunity, use only accessories and peripherals recommended by SonoSite.
Connection of accessories and peripherals not recommended by SonoSite to
the ultrasound system may result in malfunction of the ultrasound system or
other medical electrical devices in the area. Contact SonoSite or your local
representative for a list of accessories and peripherals available from or
recommended by SonoSite. See the SonoSite accessories user guide.

Electrostatic discharge
Caution: Electrostatic discharge (ESD), or static shock, is a naturally occurring
phenomenon. ESD is common in conditions of low humidity, which can be
caused by heating or air conditioning. ESD is a discharge of the electrical
energy from a charged body to a lesser or non-charged body. The degree of
discharge can be significant enough to cause damage to a transducer or an
ultrasound system. The following precautions can help reduce ESD: anti-static
spray on carpets, anti-static spray on linoleum, and anti-static mats.

16 Chapter 3: Safety
Separation distance
Recommended separation distances between portable and mobile RF communications equipment
and the SonoSite Edge II ultrasound system

The SonoSite Edge II ultrasound system is intended for use in an electromagnetic

environment in which radiated radio frequency (RF) disturbances are controlled. The
customer or the user of the SonoSite Edge II ultrasound system can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the SonoSite Edge II ultrasound
system as recommended below, according to the maximum output power of the
communications equipment.

Rated Separation distance according to frequency of transmitter

maximum m
output power
of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
Watts d=1.2 P d=1.2 P d=2.3 P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended
separation distance (d) in meters (m) can be estimated using the equation applicable to
the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects, and people.

Chapter 3: Safety 17
 Guidance and manufacturer’s declaration
WARNING: Other equipment, even equipment that complies with CISPR emission
requirements, can interfere with the SonoSite Edge II ultrasound system.

The SonoSite Edge II wireless adapter contains an IEEE 802.11 transmitter that utilizes the ISM frequency
band from 2.412 to 2.4835 GHz and implements two methods of transmission:
• IEEE 802.11b with Complementary Code Keying (CCK), Differential Quaternary Phase Shift Keying
(DQPSK), and Differential Binary Phase Shift Keying (DBPSK) at 16 dB
• IEEE 802.11g with Orthogonal Frequency Division Multiplexing (OFDM) at 13 dBm

Guidance and Manufacturer’s Declaration - Electromagnetic Emissions

The SonoSite Edge II ultrasound system is intended for use in the electromagnetic
environment specified below. The customer or the user of the SonoSite Edge II ultrasound
system should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment

RF emissions Group 1 The SonoSite Edge II ultrasound system uses RF

ClSPR 11 energy only for its internal function. Therefore, its
RF emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.

RF emissions Class A The SonoSite Edge II ultrasound system is

ClSPR 11 suitable for use in all establishments other than
domestic and those directly connected to the
Harmonic emissions Class A public low-voltage power supply network which
IEC 61000-3-2 supplies buildings used for domestic purposes.±

Voltage Complies
fluctuations/flicker
emissions
IEC 61000-3-3

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

The SonoSite Edge II ultrasound system is intended for use in the electromagnetic
environment specified below. The customer or the user of the SonoSite Edge II ultrasound
system should assure that it is used in such an environment.

Immunity IEC 60601 Test Compliance Electromagnetic

Test Level Level Environment

Electrostatic ±6.0KV contact ±6.0KV contact Floors should be wood,

Discharge ±8.0KV air ±8.0KV air concrete or ceramic tile. If
(ESD) floors are covered with
IEC 61000-4-2 synthetic material, the
relative humidity should be
at least 30%.

18 Chapter 3: Safety
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (Continued)

The SonoSite Edge II ultrasound system is intended for use in the electromagnetic
environment specified below. The customer or the user of the SonoSite Edge II ultrasound
system should assure that it is used in such an environment.

Immunity IEC 60601 Test Compliance Electromagnetic

Test Level Level Environment

Electrical fast ±2KV for power ±2KV for power Mains power quality should
Transient burst supply lines supply lines be that of a typical
IEC 61000-4-4 ±1KV for ±1KV for commercial or hospital
input/output lines input/output lines environment.

Surge ±1KV line(s) to ±1KV line(s) to Mains power quality should

IEC 61000-4-5 line(s) line(s) be that of a typical
±2KV line(s) to earth ±2KV line(s) to commercial or hospital
earth environment.

Voltage dips, >5% UT >5% UT Mains power quality should

short (>95% dip in UT) for (>95% dip in UT) be that of a typical
interruptions commercial or hospital
0.5 cycle for 0.5 cycle
and voltage environment. If the user of
variations on 40% UT 40% UT the SonoSite Edge II
power supply (60% dip in UT) for 5 (60% dip in UT) ultrasound system requires
input lines cycles for 5 cycles continued operation during
IEC 70% UT 70% UT power mains interruptions, it
61000-4-11 is recommended that the
(30% dip in UT) for (30% dip in UT) SonoSite Edge II ultrasound
25 cycles for 25 cycles system be powered from an
>5% UT >5% UT uninterruptible power supply
(>95% dip in UT) for (>95% dip in UT) or a battery.
5s for 5s

Power 3 A/m 3 A/m Power frequency magnetic

Frequency fields should be at levels
Magnetic Field characteristic of a typical
IEC 61000-4-8 location in a typical
commercial or hospital
environment.

Conducted RF 3 Vrms 3 Vrms Portable and mobile RF

IEC 61000-4-6 150 kHz to 80 MHz communications equipment
should be used no closer to
any part of the SonoSite
Edge II ultrasound system
including cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.

Recommended Separation
Distance
d = 1.2 P

Chapter 3: Safety 19
 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (Continued)

The SonoSite Edge II ultrasound system is intended for use in the electromagnetic
environment specified below. The customer or the user of the SonoSite Edge II ultrasound
system should assure that it is used in such an environment.

Immunity IEC 60601 Test Compliance Electromagnetic

Test Level Level Environment

Radiated RF 3 Vim 3 V/m d = 1.2 P

IEC 61000-4-3 80 MHz to 2.5 GHz 80 MHz to 800 MHz
d = 2.3 P
800 MHz to 2,5 GHz
Where P is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in meters (m).

Radiated RF Field strengths from fixed

IEC 61000-4-3 RF transmitters, as
(continued) determined by an
electromagnetic Site
surveya, should be less than
the compliance level in each
frequency rangeb.
Interference may occur in
the vicinity of equipment
marked with the following
symbol:

Note:UT is the AC mains voltage prior to application of the test level.

At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

a. Field strengths from fixed transmitters such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the SonoSite ultrasound system is
used exceeds the applicable RF compliance level above, the SonoSite ultrasound system should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
re-orienting or relocating the SonoSite ultrasound system.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

FCC Caution: Changes or modifications not expressly approved by the party responsible for compliance
could void the user’s authority to operate the equipment.

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
• This device may not cause harmful interference.
• This device must accept any interference received, including interference that may cause undesired
operation.

20 Chapter 3: Safety
Immunity testing requirements
The SonoSite Edge II ultrasound system complies with the essential performance requirements specified in
IEC 60601-1-2 and IEC 60601-2-37. Results of immunity testing show that the SonoSite Edge II ultrasound
system meets these requirements and is free from the following:
• Noise on a waveform or artifacts or distortion in an image or error of a displayed numerical value that
cannot be attributed to a physiological effect and that may alter the diagnosis
• Display of incorrect numerical values associated with the diagnosis to be performed
• Display of incorrect safety related indications
• Production of unintended or excessive ultrasound output
• Production of unintended or excessive transducer assembly surface temperature
• Production of unintended or uncontrolled motion of transducer assemblies intended for intra-corporeal
use

Standards
Electrical safety standards
AAMI ES60601-1:2005 + C1(2009) + A2(2010) Medical electrical equipment, Part 1: General requirements
for basic safety and essential performance (3rd edition plus Corrigendum 1 and Amendment A2)
CSA C22.2 No. 60601-1-08 + TC 2(2011) Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance (3rd edition plus Corrigendum 2)
IEC 60601-1:2005 + C1(2006) + C2(2007) Medical electrical equipment, Part 1: General requirements for
basic safety and essential performance (3rd edition plus Corrigendum 1 and Corrigendum 2)
CSA C22.2 60601-2-37:08 Medical electrical equipment - Part 2-37: Particular requirements for the basic
safety and essential performance of ultrasound medical diagnostic and monitoring equipment
IEC 60601-2-37 (ed .2.0) Medical electrical equipment - Part 2-37: Particular requirements for the basic
safety and essential performance of ultrasound medical diagnostic and monitoring equipment
CSA C22.2 60601-6-07 Medical Electrical Equipment part 1-6: General requirements for basic safety and
essential performance – Collateral Standard: Usability
IEC 60601-1-6:2010 Medical Electrical Equipment part 1-6: General requirements for basic safety and
essential performance – Collateral Standard: Usability.

EMC standards classification

CISPR 11:2009, Industrial, Scientific, and Medical (ISM) Radio-Frequency Equipment Electromagnetic
Disturbance Characteristics—Limits and Methods of Measurement.
IEC 60601-1-2:2007, Medical Electrical Equipment—General Requirements for Basic Safety and Essential
Performance-Collateral Standard. Electromagnetic Compatibility Requirements and Tests.
The Classification for the ultrasound system, docking system, accessories, and peripherals when
configured together: Group 1, Class A.

Acoustic standards
NEMA UD 2-2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.
NEMA UD 3-2004, Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on
Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine.

Biocompatibility standards
AAMI/ANSI/ISO 10993-1, Biological evaluation of medical devices—Part 1: Evaluation and testing (2009).

Chapter 3: Safety 21
 AAMI/ANSI/ISO 10993-5, Biological evaluation of medical devices—Part 5: Tests for In Vitro cytotoxicity
(2009).
AAMI/ANSI/ISO 10993-10, Biological evaluation of medical devices—Part 10: Tests for irritation and
delayed-type hypersensitivity (2002).
AAMI/ANSI/ISO 10993-11, Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
(2006).
AAMI/ANSI/ISO 10993-12, Biological evaluation of medical devices—Part 12: Sample preparation and
reference materials (2007).

Airborne equipment standards

RTCA DO-160E, Radio Technical Commission for Aeronautics, Environmental Conditions and Test
Procedures for Airborne Equipment, Section 21.0 Emission of Radio Frequency Energy, Category B. 118.

DICOM standard
NEMA PS 3.15, Digital Imaging and Communications in Medicine (DICOM)—Part 15: Security and System
Management Profiles.

HIPAA standard
The system includes security settings that help you to meet the applicable security requirements listed in
the HIPAA standard. Users are ultimately responsible for ensuring the security and protection of all
electronic protected health information collected, stored, reviewed, and transmitted on the system.

Health Insurance Portability and Accountability Act, Pub.L. No. 104-191.

45 CFR 160, General Administrative Requirements.
45 CFR 164, Security and Privacy.

22 Chapter 3: Safety
Chapter 4: System Overview

About the System

The SonoSite Edge II high-resolution ultrasound system is a portable, full featured, general purpose,
software controlled, diagnostic ultrasound system using all digital architecture. The system is used to
acquire and display high-resolution, real-time ultrasound data in 2D, M Mode, Pulsed Wave (PW) Doppler,
Continuous Wave (CW) Doppler, Color Power Doppler (CPD), and color Doppler (Color) or in a combination
of these modes.
The system has an electrocardiography (ECG) display feature and supports a 3-lead ECG cable assembly
to collect data for M Mode and Doppler measurements. The system provides measurement capabilities for
anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The
system has a PW and CW Doppler audio output feature, cine review, image zoom, labeling, biopsy,
measurements and calculations, image storage and review, printing, and recording capabilities.
The system includes optional Digital Imaging and Communications in Medicine (DICOM) capabilities as well
as general computer communication capabilities to provide the acceptance, transfer, display, storage, and
digital processing of ultrasound images and loops. Security support is also provided to facilitate HIPAA
compliance.
The system/transducer is capable of exceeding a TI or an MI of 1.0 in certain operating modes or mode
combinations. The system displays the current output level in terms of one of two bioeffects indices
(“Mechanical Index [MI]” and “Thermal Index [TI]”) in accordance with the AIUM/NEMA Standard for Real
Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment.
The SonoSite Edge II utilizes AEP-256 encryption with the internal SD card for the purpose of encrypting
Protected Health Information (PHI). The system specific encryption key is programmed at the factory and
cannot be changed. Since this key is always specific between the system and SD card, the SD card cannot
be replaced in the field and the system must be returned to the factory for repair of an SD card failure. Main
PCBA Service Assemblies will ship with an SD card installed and this card must be used when the assembly
is installed in a system to perform a repair.

Chapter 4: System Overview 23

Theory of Operation
The SonoSite Edge II ultrasound system has seven (7) major functional groups:
• Transducer
• Acquisition Subsystem
• Processing Subsystem
• Display Subsystem
• Control Subsystem
• User Interface Subsystem
• Power Subsystem
Figure 4.1 is a system block diagram that shows the relationship of the functional groups.

External video to
monitor, printer
Acquisition RF Processing AQ Display
subsystem subsystem subsystem Video
Bus Bus User
interface
IrDA
Control
subsystem Serial Bus
Control Bus

Power
subsystem
Battery
pack
Display power assembly
Transducer
Logic power

Pulser voltage

Power
adapter

External power

Figure 4.1 SonoSite Edge II High-Resolution Ultrasound System Block Diagram

The Transducer elements convert the pulser voltage to acoustic energy during the transmit portion of the
ultrasound acquisition cycle. The elements convert the acoustic echo to voltage in the receive portion of the
acquisition. The voltage developed on the transducer elements is sensed by the acquisition subsystem. The
system transducers have 64 to 256 elements.
The Acquisition Subsystem consists of the beamformer and interface to the transducer. The beamformer
controls the timing of the transmit pulses to focus the acoustic beam. The beamformer amplifies the
low-level received echos and controls the receive focusing. The system beamformer transmits on up to 128
elements and receives on 64 elements.
The Processing Subsystem includes capabilities for interfacing with the beamformer and performing high
speed processing. The processing subsystem demodulates, filters, detects, and compresses the signal
supplied by the beamformer into display information.

24 Chapter 4: System Overview

 The Display Subsystem converts the detected ultrasound data into picture elements (pixels). The software
user interface graphics are combined with the ultrasound information and converted to a video stream. The
external video port supports NTSC and PAL format.
The Control Subsystem consists of the central processing unit, program and video memory, permanent
image storage and retrieval memory, external communication interface ports, and connection to the user
interface keys. The control software includes the acoustic power and intensity software subsystem, power
group monitors, and a beamformer monitor. This software guarantees a level of patient safety by ensuring
the system is operating within acoustic power and intensity limits.
The User Interface Subsystem represents the software interface and form factor. The software interface
is the interaction between the user and the screen layout components. The form factor is the type of physical
buttons, location, and grouping of the buttons and the device size, shape, and weight. Dedicated controls
are for high usage activities and grouped according to the user workflow.
The Power Subsystem provides the system power and protects the hardware from destructive and/or
unsafe conditions by detecting failures in the system through hardware and software monitors. Detection of
a fault results in disabling of the pulser supply, and signaling of an error to the Control Group. The power
subsystem includes the battery pack and battery charging electronics.

Description of Operating Modes

2D Mode 2D mode is a two dimensional image of the amplitude of the echo signal. It is used for
location and measurement of anatomical structures and for spatial orientation during
operation of other modes. In 2D, a two-dimensional cross-section of a 3-dimensional
soft tissue structure such as the heart is displayed in real time. Ultrasound echoes of
different intensities are mapped to different gray scale or color values in the display.
The outline of the 2D cross-section may be a rectangle, parallelogram, trapezoid,
sector, or a full circle, depending on the particular transducer used. 2D mode can be
used in combination with any other modes.

M Mode M Mode is also known as “T-M mode” or “time-motion” mode. It is used primarily for
cardiac measurements such as valve timing and septal wall thickness when accurate
timing information is required.
Ultrasound echoes of different intensities are mapped to different gray scale values in a
scrolling display. M Mode displays time motion information of the ultrasound data
derived from a stationary beam. Depth is arranged along the vertical axis with time
along the horizontal axis. M Mode can be used alone but is normally used in
conjunction with a 2D image for spatial reference. The 2D image has a graphical line
(M-line) superimposed on the 2D image indicating where the M Mode beam is located.

Chapter 4: System Overview 25

 Color In color Doppler, a real-time, two-dimensional cross-section of blood flow is displayed
Doppler in a Region of Interest (ROI) box. The 2D cross-section may be presented as a
(Color) rectangle, parallelogram, trapezoid or sector, depending on the particular transducer
used.
The ROI is presented as a full color display, with various colors being used to represent
the velocity, both positive and negative, of the blood flow echoes. This is used to
evaluate the speed and direction of blood flow. Often, to provide spatial orientation, the
full color blood flow cross-section is overlaid on top of the gray scale cross-section of
soft tissue structure (2D echo). For each pixel in the overlay, the decision of whether to
display VCD, gray scale (echo) information or a blended combination is based on the
relative strength of echoes from the soft-tissue structures and from the red blood cells.
A high pass filter (wall filter) is used to remove the signals from stationary or slowly
moving structures. Tissue motion is discriminated from blood flow by assuming that
blood is moving faster than the surrounding tissue, although additional parameters may
also be used to enhance the discrimination. The remaining signal after wall filtering
may be averaged over time (persistence) to present a steady state image of blood flow
distribution. Variance information may also be displayed to provide information when
large variance is observed in the velocity information.

Color Power In CPD, a real-time two-dimensional cross-section of blood flow is displayed in a

Doppler Region of Interest (ROI) box. The 2D cross-section may be presented as a rectangle,
(CPD) parallelogram, trapezoid, sector, depending on the particular transducer used.
The ROI is presented as a full color display, with various colors being used to represent
the power (amplitude) of blood flow echoes. This is used primarily to detect the
presence or absence of flow; it does not indicate velocity. Often, to provide spatial
orientation, the full color blood flow cross-section is overlaid on top of the gray scale
cross-section of soft tissue structure (2D echo). For each pixel in the overlay, the
decision of whether to display CPD, gray scale (echo) information or a blended
combination is based on the relative strength of echoes from the soft-tissue structures
and from the red blood cells.
A high pass filter (wall filter) is used to remove the signals from stationary or slowly
moving structures. Tissue motion is discriminated from blood flow by assuming that
blood is moving faster than the surrounding tissue, although additional parameters may
also be used to enhance the discrimination. The power in the remaining signal after
wall filtering may be averaged over time (persistence) to present a steady state image
of blood flow distribution.

Continuous CW provides a real-time representation of blood flow and is displayed as a

Wave (CW) velocity-versus-time sweeping output. Velocity (or frequency) is presented as the
Doppler vertical axis with time along the horizontal axis. The magnitude of the detected signal is
represented as different gray scale values.
CW Doppler mode provides the clinician with the ability to obtain blood flow velocities
focused about a user specified focal region. A continuous transmit waveform of
ultrasound energy with a known frequency is transmitted and focused by the system;
on the receive side, the transducer receive echoes are continuously amplified, focused
about the focal region and converted to a base band quadrature signal. The signal is
analyzed by a quadrature phase detector that establishes two receive channels to
allow detection of flow direction. These two channels are then analyzed by a fast
complex Fourier transform (FFT) circuit to establish the spectrum of frequencies
present in the echoes. The data are displayed as spectrum frequencies with respect to
time.
CW can be used alone but is normally used in conjunction with a 2D image for spatial
reference. The 2D image has a graphical line (D-line) superimposed on the 2D image
indicating where the CW beam is located.

26 Chapter 4: System Overview

 Pulsed Wave PW provides a real-time representation of blood flow and is displayed as a
(PW) velocity-versus-time sweeping output. Velocity (or frequency) is presented as the
Doppler vertical axis with time along the horizontal axis. The magnitude of the detected signal is
represented as different gray scale values. The ultrasound data is derived from a single
area, the sample volume, on a stationary beam.
PW Doppler mode provides the clinician with the ability to obtain blood flow velocities
about a spatial sample volume. A burst of ultrasound with a known spectrum is
transmitted by the system; on the receive side, the transducer receive echoes are
amplified and range gated at the appropriate depth. The signal is analyzed by a
quadrature phase detector that establishes two receive channels to allow detection of
flow direction. These two channels are then analyzed by a fast complex Fourier
transform (FFT) circuit to establish the spectrum of frequencies present in the echoes.
The data are displayed as spectrum frequencies with respect to time.
PW is used in conjunction with a 2D image for spatial reference. The 2D image has a
graphical line (D-line) superimposed on the 2D image indicating where the PW beam is
located. The sample volume position (depth) and size are also indicated on the D-Line.

Additional System Feature Performances

Broadband Imaging This ultrasound acquisition system uses high resolution broadband technology
in the transmit pulsers, transducer, and receivers. The receive path can capture
and process signals over a wide spectrum, from below 2.0 MHz to beyond 10
MHz. For each application, the transmit pulse is designed to produce an
appropriate bandwidth. For example, in 2D grayscale imaging, a wide band
pulse is used to support good axial resolution. For Doppler modes, a narrower
band pulse is used, which improves the spectral resolution of the detected
Doppler signal.
In addition to transmit pulse control, programmable digital signal processing is
used in the receive path to further refine the bandwidth used to produce the
final image. Digital filters are applied to the digitized received signal to limit and
shape the spectral bandwidth used to generate the displayed output.

Tissue Specific In this feature, parameters for signal and image processing are optimized to
Imaging maximize the image quality or to obtain the best compromise of resolution and
penetration for different specific clinical applications. These parameters
include: the order of received filters, the bandwidth, the dynamic range, the
compression curve, the gain setting and parameters for compounding
frequency band, etc. For example, different system parameter setups are used
for abdominal or peritoneal scanning. This feature is for ease of use for the
operator by automatically setting up system control parameters rather than
manually adjusting settings for best performance.

Biopsy Guidance The system can display a pair of biopsy guidelines that represent the
anticipated path of the biopsy needle. The image of an anatomical target,
biopsy guidelines, a scan plane marker, and a biopsy needle are displayed to
assist in guiding the biopsy needle to the target. The system also provides
needle guidance for vascular access procedures. For additional information,
see the biopsy user guides.

Measurement and The system offers a variety of measurements and calculations, specific to
Calculation exam type and transducer. A list of them, and author references, are in the
Capabilities system user guide. Measurement accuracy is also discussed.

Chapter 4: System Overview 27

 Continuous Wave The system provides for audio output of the CW velocity information. This can
Doppler Audio be presented as stereo information, with flow moving towards the transducer
Output on one channel and flow away on the other, or as a mono output with the single
audio output representing the summation of the flow directions.

Pulsed Wave The system provides for audio output of the PW velocity information. This can
Doppler Audio be presented as stereo information, with flow moving towards the transducer
Output on one channel and flow away on the other, or as a mono output with the single
audio output representing the summation of the flow directions.

Electrocardiograph ECG is provided to measure the electrical signal generated by the heart. A
(ECG) Display three lead interface: Right Arm (RA), Right Leg (RL) and Left Leg (LL), is
provided on the system.
The ECG signal is displayed as an amplitude-versus-time sweeping output.
Amplitude is presented on the vertical axis with time along the horizontal axis.

Front End Overview

The Front End is designed to support various imaging modalities such as 2D, M-Mode, Spectral Doppler
and Color Doppler. From the Front End's perspective, all modes can be grouped into a few basic types:
Single mode, simultaneous modes and triggered modes. All these modes are built from similar, basic
transmit and receive sequences controlled within the Front End. A generic top level block diagram of a
typical Front End is in the figure below.

Transducer Receive Section

T/R Sw

A/D Delay X

TGC Amplifier Weight

Beamformed
Pulser Delay Data

Waveform

T/R Sw

A/D Delay X

TGC Amplifier Weight

Pulser Delay

Waveform Control

Transmit Section

Figure 4.2 Front End Block Diagram

The transmit section consists of a waveform generator, delay block, and high power high voltage driver to
excite the transducer element. Multiple elements are driven with delays determined by the time of flight in
the medium from the elements to the point in space where the beam is to be focused. The longer the time
of flight is to the focal point the smaller the delay is for a given transmit element to allow all to arrive at the

28 Chapter 4: System Overview

focal point at the same time. The number of elements driven is determined by element sensitivity off axis
and depth of field considerations. The waveform is selected to drive the transducer at a certain center
frequency, bandwidth, and power and is optimized for the given mode.

The receive section consists of a transmit/receive switch to protect the receiver from the transmit voltage, a
variable gain receiver to amplify and condition the return echoes, an A/D to digitize the data, a delay block
to focus the return signals and a weight block to scale the return echoes for each channel. All the signals
are then summed together to generate the beam-formed receive data. The analog gain varies with depth
to compensate for signal attenuation through the medium. The delays and weights are independent for
each channel. The delay and weight for the receive channel can typically be changed dynamically to keep
the receive beam in continuous focus. The delay is simply set by the time of flight in the medium from the
point of interest to the element, which starts at skin-line and proceeds to the deepest depth of interest.

The control section drives the data to the various data path elements on a line by line basis, controls the
timing of the transmit and receive sections and controls the tagged information and timing of the data to the
rest of the system.

Chapter 4: System Overview 29

PW Doppler Processing
Doppler processing includes both audio processing which presents Doppler signal in the form of stereo
audio and spectral processing which generates data for display of Doppler spectrum in the form of a
scrolling spectrogram. Doppler power spectrum is estimated performing Discrete Fourier Transforms on
short, overlapped segments of wall filtered Doppler signal. Doppler audio data is generated from wall filtered
data by phase shifting the in-phase component.PW Doppler Processing Function Block Diagram

Peak &
Mean
Back
End
Temporal Baseline Display
Compress
Averaging shift Interpolate

Wall Post
QBP Resample Window FFT |.|
Filter Gain
RF

Audio Output

indicates IQ pairs
I Hilbert + + Audio
Phase Shifter Gain
+
+ 2x16 bits @ PRF rate
Audio
Delay +
Q - Gain

Figure 4.3 PW Doppler Processing Function Block Diagram

30 Chapter 4: System Overview

CW Doppler Processing
CW Doppler data will be presented to the signal processor as complex (I/Q) data from the analog front end
of the external DSP. The 16-bit data will be presented as consecutive samples at a data rate varying from
1.5 kHz to 64 kHz for the complex pair. Most of CW processing is similar to that of PW except for the QBP
function. In place of QBP will be a low pass decimating filter that operates on incoming I/Q data.

The Doppler Processing block must allow storage of 128 undetected I/Q pairs in to allow the system to
measure and correct for phase mismatch. Measuring and correcting will need to be accomplished in system
software.

MuxMux

CW Asic
CW Asic PCB PCB DSP DSP

Amplifier
Amplifier
Other Channel with
Other
same Channel with
Delay
same Delay

Freq LO I
Q
Freq LO Gen LO I
Delay LO Q
LO Gen
Delay
Master Clk LO Q
I
Master Clk
Q

I Q Q Q Q Q Q Q Q
A/D A/D Complex
Complex
QSum QSum Wall Filter/ To To Doppler
Doppler
Wall Filter/ A/D Filter BP PRF
I-V I-V I I A/D Filter I I
I
BP PRF Processing
Processing
I
I Sum I Sum I FilterFilter I
A/D A/D

I Sample Clock
Sample Clock
Mux Q
I

Q
Mux Amplifier
Other Channel with
same Delay

Amplifier Freq LO I
Other Channel withLO Gen
Delay
same Delay LO Q
Master Clk

Freq LO I
LO Gen
Delay LO Q
Master Clk

Figure 4.4 CW Doppler Processing Function Block Diagram

Chapter 4: System Overview 31

Back End Overview
The Back End subsystem is responsible for the conversion of raw acquisition data into a raster image ready
for display. The Back End subsystem also contains the video data path that supports generation of video
comprising of the ultrasound image as well as graphics annotation. Video generation of both standard
composite interlaced video and progressive scan video is supported. Most functionality is within the ASIC
but the memory resources for acquisition memory, and display memory are found in external memory
components. The conversion from PC type video to TV type video is also performed externally.
Control is received initially from the CPU to setup each functional block and afterward the hardware is
completely data driven. This control takes the form of programming setup registers inside the blocks and
setting up scan conversion tables. Each block provides temporary storage as required to buffer data and
keep their respective processing pipeline full and operating. Also note that the block diagrams show only
the data path, but each block is responsible for generating any necessary memory addresses for their
respective input data stream.
The SonoSite Edge II Back End subsystem is shown in the figure below.

Figure 4.5 Back End Subsystem Block Diagram

The Back End Subsystem performs processing encompassing three main data domains, acquisition data,
raster data, and video data. Support for acquisition data includes the input buffer, flash suppression, frame
average, and external ACQ memory. Cine buffer management is performed by the acquisition controller.
Conversion from acquisition data to raster data is performed by the graphics overlay, scan conversion
engine, sweeping engine, and 3D engine. Raster data is stored in an external DISPLAY memory. Also
supporting raster operations is the graphics support block that provides acceleration hardware for pixel
operations from the CPU and graphics overlay engine. Video data is processed as progressive scan and
supplied externally on a digital bus. In addition, interlaced video is supplied in both composite and S-video
formats. The progressive video path includes buffers, priority logic, and LUTs. External video in signals are
input and multiplexed onto the external video out path to allow for external sources to display information
on connected displays, VCRs, or printers.

32 Chapter 4: System Overview

Control Subsystem
The SonoSite Edge II Control Subsystem is shown in the figure below.
SYSPWR,
INFRASTRUCTURE SYSCLKS, MASS
SYSRST EXPANSION STORAGE

ETHERNET FAST
ETHERNET

SYSTEM SYSTEM
FLASH RAM
PCI BUS

2 U/I, DEBUG
PCI BRIDGE DUAL UART,
USB
USB

DATA
SYSTEM BUS ADDRESS
CONTROL

SH MUX
SYSTEM IIC SH CONTROL
FLOATING
TIMERS DMA CONTROLLER
POINT CONTROL
cache

SH BUS
INTERRUPTS
PROCESSOR

8 GPIO ULTRASOUND VIDEO

JTAG SCANHEAD
DATA PATH AUDIO

ECG

IIC BUS DATA

CONTROL

Figure 4.6 Control Subsystem Block Diagram

The core control subsystem contains the processor, the system bus, the system memory resources of
FLASH and RAM, the interrupt logic, system timers, a DMA engine, and a floating point unit. Support for
the ultrasound subsystem consists of a scanhead interface, scanhead mux control.

Communication interfaces consists of an Ethernet interface, USB port, two general purpose serial bus
interfaces, and the IIC bus. The SonoSite Edge II control architecture is an open architecture. It supports
functionality extension through the incorporation of the PCI bridge to the PCI bus. Functionality may be
added by adding to the PCI Bus.

Chapter 4: System Overview 33

Power Supply and Control
The SonoSite Edge II Power Supply and Control System consists of an easily replaced rechargeable battery
pack; an On/Off Key; a standby power regulator; digital, analog, display and transducer power supplies; a
power monitor and a power control system. Operating current is drawn from the battery or an external
AC/DC Adapter which also contains circuitry for charging the battery. A fan and provision for a temperature
sensor are also included.

VEXT Standby Power VSTBY

Regulator
Power
VEXTS
Select On/Off
VBAT VBATS On/Off Key
Latch
Power PWR_Enable
Switch
VPWR
VCC(n)
Digital VCC1
Off
Power VCC1_Good RSTN
Supplies
DPS_Enables
CPU
PS Bus
VEXTS
Battery
Pack
+HVB
+HV
+6V
Analog
-6V
Power
Supplies HV_ADJ Power
APS_Enable Monitor
APS_Sense and
Control
Fan Fan_Enable Temp
Sense
BL_PWR
Display LCD(n)
Power LCD_Control
Supplies LCD_Enable

SH_5V
Transducer
SH_3.3V
Power
SH_VPP
Supplies SH_Enable

Figure 4.7 Power Supply and Control Subsystem Block Diagram

34 Chapter 4: System Overview

Battery Pack (VBAT)
A rechargeable lithium-ion battery pack will be used to operate the unit in battery mode. The pack will
include a capacity monitoring circuit and any required pack protection circuitry. A one-wire, bidirectional,
serial interface (BDATA) will be used to read and write the pack data.

Battery Charger
The charge circuitry is in the external AC/DC Adapter as shown in the following block diagram.

POWER SUPPLY / BATTERY CHARGER Output Cable SYSTEM

Voltage +15VDC
5 5
Source

Universal Current Limited Current VCHG VBAT+

2 2
AC Voltage Source Sense
Input
Ferrite /
Line Common
Mode Choke
Neutral Ferrite
3 turns on
Ground Ferrite RATE/SYNC
3 3
Charge System
Control 20K Power
Voltage 2K Supply
0.1 R2 VSENSE VBAT-
10 Sense 4 4
UF UF
.C57
.01uF PWR_RETURN
1 1
Cable Shield

Figure 4.8 Battery Charging Subsystem Block Diagram

Chapter 4: System Overview 35

ECG Module
The ECG module allows a representation of the heart electrical activity to be displayed in real time with
ultrasound images acquired and displayed on the system video display.
The ECG module interfaces to the patient through three (3) ECG leads: Right Arm ECG lead (RA), Right
Leg ECG lead (RL), and Left Leg ECG lead (LL). The ECG received signal from the ECG electrodes are
isolated, amplified, and filtered by the ECG module before it is sent to the system for further processing and
display.
The ECG module and cable are an integrated assembly. The module receives power from the system.
Patient isolation is provided by the ECG module, allowing the connection and signals to the system to be
system-ground referenced. The isolation between the patient and the system meets the requirements of IEC
601-1 for Type CF equipment.
The ECG function accepts input from an external serial A/D and performs gain, filter, DC Offset and trigger
functions. The resultant data is output at either the 200Hz sample rate or decimates the data by 2 or 4 and
outputs the data into acquisition memory. The data is assumed to be signed. The ECG trigger function is
implemented by a simple edge sensitive trigger along with SW monitoring the ECG data and triggering the
FE after a user defined delay from the detected R wave. An interrupt is provided that will interrupt the
processor after a set delay from the detected level and slope. A simple block diagram of the HW is shown
below.

Figure 4.9 ECG Block Diagram

36 Chapter 4: System Overview

DICOM
The system features Digital Imaging and Communications in Medicine (DICOM) capability to provide the
acceptance, transfer, display, storage, and digital processing of single ultrasound images as well as loops
of ultrasound images.

Chapter 4: System Overview 37

38 Chapter 4: System Overview
Chapter 5: Troubleshooting

This chapter contains information to help you correct problems with system operation.
Note: If the system requires repair, certain steps must be taken to remove patient data from the system prior to
return to FujiFilm Sonosite. To accomplish this, a Power-0 Reset must be performed whenever possible (certain
conditions may prevent this, such as a system that fails to power on).

Power-0 Reset formats the system SD memory.

Warning: This will erase all patient data saved on the system, but will not delete an already
established partition for the transducer database.Patient images should be exported or archived
before proceeding.
The procedure for performing the Power-0 Reset is as follows:
Start with the system powered off.
1) Press and hold the "0" key.
2) Press and release the system On/Off button while continuing to hold down the "0" key.
3)When the system emits a high-low sound, release the “0” key. This sound will occur after 5-10
seconds and indicates that the system is reset. The reset will be complete about 1 minute after the
system has booted up, when the system emits a low-high sound.

Power-1 Reset causes the system settings to revert back to factory defaults. This includes the
following:
Sets system date/time to January 1, 2003, 02:00.
Sets IP address to 169.254.254.254. DICOM or SiteLink network configurations already saved to
the system will still present, but must be selected again in the Connectivity screen.
Resets the Audio, Battery settings.
The procedure for performing the Power-1 Reset is as follows:
Start with the system powered off.
1) Press and hold the “2D” key.
2) Press and release the system On/Off button while continuing to hold down the “2D” key.
3) Release the when the system emits a high-low then low-high sound. This sound will occur after
5-10 seconds and indicates that the system is reset.

System and Subsystem Diagnosis

This section covers basic diagnostic and troubleshooting procedures you may follow if the system
does not operate properly. To diagnose system failures, consult the referenced diagnostic figures
that follow or SonoSite Technical Support.
Table 5.1: Troubleshooting Subassemblies and Diagnostic Figures

Subassemblies Diagnostic Figures or Table

DICOM Table 5.2

Display Table 5.3

Battery Table 5.4

Control Panel Table 5.5

Chapter 5: Troubleshooting 39
System Repair
The system is repairable through subassembly replacement or through replacement of parts as
recommended by SonoSite. Component level repair of Printed Circuit Board Assemblies is
performed only at the SonoSite repair facility. Replacement of board level components by
unauthorized service facilities voids the SonoSite warranty and will prevent receipt of credit on a
returned assembly.

Test Equipment
Test equipment is not required for this troubleshooting section. Troubleshooting test aids include an
external monitor and a spare battery.

Failure (Assert) Codes

The system displays an “assert screen” for hardware and software issues related to Main PCBA
failures. Main PCBA failures typically result in “assert codes” that are output to the display. If an
assert screen appears, note the assert information and contact SonoSite Technical Support to
clarify the failure. Figure 5.1 shows an assert screen. The assert information required is the
information listed on the“P”: line, “C:” line and the “D:” line.

Record all information on the“P”: line,

“C:” line and “D:” line and contact
Technical Support

Figure 5.1 Assert Screen

Verifying a System Assert Code

System asserts are caused by hardware and/or software faults. Hardware asserts typically require
main PCBA replacement. Software asserts can be reset and the system may recover. A simple
method to identify the cause of the assert is identified here:

Assert Cause 1 Record the assert code.

2 Press and release the Power button to power the system down.
3 Press the Power button again to power on the system.
• If the system powers on normally, it has recovered from the fault (software assert)
and you may use the system.
• If the assert condition remains, corrective action must be taken; usually
replacement of the main PCBA is required. Contact SonoSite Technical Support for
assistance and to obtain repair parts.
If the Power button is not functional, all sources of power must be removed to allow
the system to power down. That is, disconnect AC power and remove the battery.

40 Chapter 5: Troubleshooting
DICOM

Table 5.2: DICOM Troubleshooting

Error
Tiller Error Code Cause Troubleshooting
Message

Socket TSOCKET_CONNECT_FAILURE Invalid network Using Ping, verify that the

communication configuration. Printer/Archiver is connected.
failed Wrong port • If Ping fails, check the
number. devices IP address, SonoSite
Application is not Edge II IP address, Subnet
running. mask, and Gateway IP
Printer is offline. address.
• If Ping is OK, use Verify to
check if device is available.
If Verify fails:
a) Check the
Printer/Archiver’s Port
configuration on the SonoSite
Edge II.
b) Ensure that the Printer is
online and the Archiver’s
application is running.

Archiver TDICARCH_OPEN_FAILURE Wrong Capture Verify that the Archiver supports

transaction Type selected the selected Capture Type
failed setting, e.g., US Image, SC
Image or US-Ret Image.

Printer TDICPRNT_OPEN_FAILURE Wrong Image Verify that the printer supports

transaction settings the selected Image settings.
failed E.g,. Color (RGB) or Grayscale
(Monochrome)

DICOM TDNETWORK_OPEN_FAILURE Device does not Verify that SonoSite Edge II AE

network recognize Title or IP address is correctly
communication SonoSite Edge II, configured on the
failed rejects Printer/Archiver.
association Note: Some devices require
that the Imaging modality
(Edge) be recognized in order
to accept images. This requires
configuration on the device.

Internal failure TDNETWORK_READ_FAILURE Invalid DICOM Check SonoSite Edge II Printer

detected Attribute DICOM settings for correctness
(e.g., film size, format)

Chapter 5: Troubleshooting 41
Display
Table 5.3: Display Troubleshooting

Problem Cause Troubleshooting

No Faulty Display Connect system to Mini-Dock and feed video to external monitor
Display or Main PCBA • If the video is not present on the external display, the Main
PCBA is likely at fault.
• If the video is present on the external display, the Display
Assembly is likely at fault.

Display Faulty Display Connect system to Mini-Dock and feed video to external
Image or system fault monitor
Quality • If the issue is present on the external monitor, the issue is
Issue caused by a fault on the system.
• If the issue is not present on the external monitor, the
Display Assembly is likely at fault.

Battery
Table 5.4: Battery Troubleshooting

Problem Cause Troubleshooting

Will not Battery Issue • Remove battery. Inspect battery and battery compartment
power contacts for damage/corrosion. Install battery and try again.
on • Remove battery and connect system to AC power only. If it
works, try a different battery.
• If issues still exist, attempt to charge the battery or replace it.
• Check the lot code on the battery. If older than 3 years,
battery may be past useful life period.

Control Panel
Table 5.5: Control Panel

Problem Cause Troubleshooting

LED not working/key(s) not Control Panel failure Perform checks in the following
responding/touchpad issue order:
• Check internal cable
connections
• Replace compression
connector
• Replace Control Panel
• Replace Main PCBA

42 Chapter 5: Troubleshooting
Chapter 5: Troubleshooting 43
44 Chapter 5: Troubleshooting
Chapter 6: Replacement Procedures

Caution:
Always use correct ESD procedures. ESD damage is cumulative and may not be noticeable at first. Initial
ESD symptoms may be slightly degraded performance or image quality.
Caution:
All fasteners should be torqued to 5.5-inch pounds except where noted, such as the Control Panel
Subassembly which should be torqued to 3.0-inch pounds.
Note: When repairs are performed, the system should be fully tested in accordance with Chapter 8.

Display Replacement

Required Parts
One of the following:
• P21147-XX Service Assembly, Display, SonoSite Edge II
• V21147-XX Vet Service Assembly, Display, SonoSite Edge II

Required Tools
• #1Phillips screwdriver
• #2 Phillips screwdriver
• Torque screwdriver, 2.0-10.0 inch pounds (0.23-1.1 newton meter)
• An anti-static mat
• A wrist grounding strap

Display Removal
(Please be advised that the SonoSite Edge II Display is a complete assembly comprised of the top cover,
display frame, wiring harnesses, hinges, and bezel. Do not attempt to replace the LCD as this is not possible
as a field replacement.)
Display Removal
1 Lay the system on its top exposing the bottom section and remove the system battery.
2 Place system on table resting on the handle. Remove 2 Hinge Cover screws with a #2 Phillips screw
driver per Figure 6.1 and remove Hinge Cover.

Figure 6.1 Hinge Cover

Chapter 6: Replacement Procedures 45

 Figure 6.2 Control Panel Screw

3 Remove the screw securing the Control Panel to the midframe as shown in Figure 6.2.
4 Remove the eight screws from the Bottom Enclosure of the system with a #2 Phillips screw driver per
Figure 6.3.

Screws (8x)

Note: the two screws

marked in red are longer
and need to be placed
in the same location when
reassembled

Figure 6.3 System Bottom

5 After removing the Bottom Enclosure, remove the two screws and flex cable indicated in Figure 6.4.
Note: the fan assembly next to the TGC blocks access to the screw on the right side so it must be
removed. To do this, remove the two screws securing the TGC which will allow it to pop up. This will
provide enough room for the fan assembly removal.

46 Chapter 6: Replacement Procedures

 Remove flex cable from
TGC assembly

Don’t forget these two

screws to release the
Control Panel. (Refer to
arrow lines in the figure
to the left).

Remove two screws in

TGC to allow fan access.

Figure 6.4 Main Frame Bottom

6 Turn the system over, fully open the display, and lift the control panel per Figure 6.5.

Lift control panel from

the front.

Figure 6.5 System Control Panel View

7 Expose the underside of the Control Panel by lifting from under the front edge and hinge via the top
edge toward the LCD display per Figure 6.6.

Chapter 6: Replacement Procedures 47

 J5
J4

J6 J7

Figure 6.6 Control Panel Removal

8 Remove the J5 “LCD IN”, J6 “LCD OUT” and J7 “BL IN” cables by gently pulling away from their sockets.
9 Remove the J4 “SPI” ribbon cable after unlocking the dark gray retainer on the socket as shown in
Figure 6.7. The control panel can now be removed..

Caution:
J4 requires the gray lock tab to be
lifted at the end closest to the
ribbon cable. Use care as the lock
tab hinge points are fragile.
J4

Figure 6.7 Control Panel Bottom

10 Tilt the system back onto the top cover allowing the LCD to lie on its back.
11 Remove the 4 screws from the LCD display hinges as shown in Figure 6.8 and remove the display LCD.

48 Chapter 6: Replacement Procedures

 Hinge Screws (4x)

Note: The orientation of the

trackpad brace is important.
The boss in the brace keys
into the hole in the midframe.
Also note the geometry of the
pocket circled in red.

Figure 6.8 Display Screws

Display Replacement
Display Replacement
1 Set the new Display Assembly in place.
2 Install the four hinge screws that hold the Display Assembly in place. Torque the screws to 8.0-inch
pounds.
3 Place the Control Panel onto the SonoSite Edge II frame.
4 Connect the Display Assembly cable (J6 “LCD OUT”) to the Control Panel and display and BLI cables
(J5 “LCD IN” & J7 “BL IN”) from the Main PCBA to the Control Panel.
5 Connect the ribbon cable (J4 “SPI”). Lock the J4 cable retainer in the closed position.
6 Place the control panel on the base assembly, carefully inserting the gain assembly through the mid
frame.
7 Close the Display Assembly and turn the system over.
8 Reinstall the flex cable from P605 on Main PCBA to TGC assembly and two screws that hold the Control
Panel in place per Figure 6.4. Torque the screws to 3.0-inch pounds.
9 Install the bottom enclosure and the eight screws on the base of the system per Figure 6.3. Torque the
screws to 5.5-inch pounds.
10 Install the Control Panel screw removed per Figure 6.2. Torque to 1.8 inch pounds taking care not to
strip the threads in the Control Panel.
11 Install the Hinge Cover and two screws removed per Figure 6.1. Torque the screws to 3.0-inch pounds.

Test the Display

Test Display
1 Replace the battery or attach an external power supply.
2 Press the Power key to apply power to the system.
3 Verify the display operates correctly.

Control Panel Subassembly Replacement

Chapter 6: Replacement Procedures 49

Required Parts
One of the following:

Service Assembly Control Panel Vet Service Assembly Control Panel

P21581-XX Control Panel, SonoSite Edge II, V21581-XX Control Panel, SonoSite Edge II,
English English

P21582-XX Control Panel, SonoSite Edge II, V21582-XX Control Panel, SonoSite Edge II,
French French

P21583-XX Control Panel, SonoSite Edge II, V21583-XX Control Panel, SonoSite Edge II,
German German

P21584-XX Control Panel, SonoSite Edge II, V21584-XX Control Panel, SonoSite Edge II,
Spanish Spanish

P21585-XX Control Panel, SonoSite Edge II, V21585-XX Control Panel, SonoSite Edge II,
Italian Italian

P21586-XX Control Panel, SonoSite Edge II, V21586-XX Control Panel, SonoSite Edge II,
Portuguese Portuguese

Note: Systems with part number P20680-16 and above have an improved control panel that corrects a
previous issue with delamination. It also has new circuitry to resolve earlier issues with backlight LED and
audio failure. Moving forward, this version of the control panel will also be installed on previous systems
with part numbers P20680-14 and below that require a new control panel. The earlier version systems will
need the midframe replaced to accommodate the new control panel. The part numbers for the existing
service assemblies will not change, but will contain the new items.

Description P20680-16 P20680-14

Vet V20680-16 V20680-14

Non-RoHS P23610-16 P23610-14

Non-RoHS Vet V23610-16 V23610-14

Japan P24028-04 P24028-03

Japan Non-RoHS P21590-04 P21590-03

Table 1: P20680-XX system equivalents

Required Tools
• #1 Phillips screwdriver
• #2 Phillips screwdriver
• Torque screwdriver, 2.0-10.0 inch pounds (0.23-1.1 newton meter)
• An anti-static mat
• A wrist grounding strap
Caution:

50 Chapter 6: Replacement Procedures

 Always use correct ESD procedures. ESD damage is cumulative and may not be noticeable at first. Initial
ESD symptoms may be slightly degraded performance or image quality.

Control Panel Removal

Control Panel Removal
1 Lay the SonoSite Edge II System on its top exposing the bottom section and remove the system battery.
2 Remove the 8 screws from the Bottom Enclosure of the system using a #2 Phillips screwdriver per
Figure 6.3.
3 Remove the ribbon cable from P605 on Main PCBA to TGC and 2 screws in the SonoSite Edge II Main
Frame securing the Top Enclosure per Figure 6.4.
4 Turn the system over, fully open the Display Assembly, and remove the Control Panel per Figure 6.5.
5 Expose the underside of the Control Panel by lifting from the front edge and hinge via the top edge
toward the LCD display.
6 Remove J5 “LCD IN”, J6 “LCD OUT” and J7 “BL IN” cables by gently pulling away from their sockets.
7 Remove the J4 “SPI” ribbon cable after unlocking the dark gray retainer socket as per Figure 6.7.
8 Lift off the loose and un-tethered Control Panel assembly from the SonoSite Edge II frame.

Control Panel Replacement

Control Panel Replacement
1 Place the new Control Panel onto the SonoSite Edge II frame.
2 Expose the underside of the Control Panel by lifting from the front edge and hinge via the top edge
toward the LCD display.
3 Connect the J4 “SPI” ribbon cable and lock the dark gray retainer on socket as shown in Figure 6.7.
4 Connect the J6 “LCD OUT”, J5 “LCD IN”, and J7 “BL IN” cables as shown in Figure 6.6.
5 Place the control panel on the base assembly carefully inserting the gain assembly through the mid
frame.
6 Close the display and turn the system over.
7 Install the ribbon cable from P605 on the Main PCBA to TGC and 2 screws in the SonoSite Edge II Main
Frame securing the Top Enclosure per Figure 6.4. Torque the screws to 5.5-inch pounds.
8 Install the eight screws on the Bottom Enclosure of the system per Figure 6.3. Torque the screws to
5.5-inch pounds.

TGC Assembly Removal

Caution:Extreme caution should be used in TGC removal and this should only be attempted if there is a
known issue with the TGC and a replacement is available. The posts are easily broken considering the
amount of force that may be required for removal.
TGC Assembly Removal
1 Lay the Control Panel on its top, exposing the bottom with the TGC Assembly on the right and remove
2 screws shown in Figure 6.9.
2 Carefully lift the TGC PCBA off the 2 standoffs it is mounted to. Be careful to keep track of the washer
on each standoff if present. It will likely take considerable force to separate the TGC PCBA from the
knobs. A flat blade screwdriver may be used to carefully pry each TGC Assembly post from the knob in
the control panel.
3 If the TGC knobs need to be removed for any reason, remove the phillips screw holding the two parts
together and separate.
Note: These steps assume the Control Panel has been removed from the system. The TGC may also be
removed while the Control Panel is still installed in the system. Refer to Figure 6.4

Chapter 6: Replacement Procedures 51

 Remove these screws

Figure 6.9 TGC Removal

Main System Disassembly for Repair and/or Replacement

Caution:There have been reports of replacement Main PCBA exhibiting assert 17138. This happens when power
is applied to the board and the system attempts to boot up without a properly connected control panel. This can
also happen during reassembly after repair. Therefore, it is vital that all appropriate documentation is followed
during the disassembly and reassembly process and the system must have the Control Panel properly installed
before applying power to prevent this assert from happening.

Required Tools
• #1 Phillips screwdriver
• #2 Phillips screwdriver
• Torque screwdriver, 2.0-10.0 inch pounds (0.23-1.1 newton meter)
• 2 mm allen key
• An anti-static mat
• A wrist grounding strap
Caution:
Always use correct ESD procedures. ESD damage is cumulative and may not be noticeable at first. Initial
ESD symptoms may be slightly degraded performance or image quality.

System Disassembly
System Disassembly
1 Remove the battery.
2 Remove the Bottom Enclosure from the system following the removal procedures in “Display Removal”
on page 39.
3 Remove the Control Panel from the system following the removal procedures in “Display Removal” on
page 40.
4 Follow the cable removal from the procedure in “Display Removal” on page 41/42. This exposes all of
the replacement parts for the main system per Figure 6.10.

52 Chapter 6: Replacement Procedures

 Major System Components

Main PCBA
USB Extension Fan x2
PCBA
Nest Frame Assembly
SD Card (on Main
PCBA under shield)

Power Supply PCBA

(under shield)
TGC

Speaker Speaker

Figure 6.10 System Components

Speaker Replacement

Required Part
• P03872 Speaker Assembly
Caution:
Use caution when removing the left speaker connector to prevent damage to the Main PCBA components
around the connector.
Speaker Replacement
1 Press on the connector release and pull the connector out of the receptacle.
2 Gently pry off the retaining clip with a flat bladed pry tool. See Figure 6.11.
3 Remove the speaker.
4 Replace the speakers by reversing steps 1-3.

Connector

Speaker

Retaining Clip

Figure 6.11 Speaker Replacement

Chapter 6: Replacement Procedures 53

Power Supply PCBA Replacement

Required Part
• P08850-XX Service Assembly, Power Supply, M-Turbo (Compatible with the SonoSite Edge II system)
• V08850-XX Vet Service Assembly, Power Supply, M-Turbo
Power Supply Removal
1 Remove the 7 long screws and 2 short screws holding the Power Supply Shield lid. Please note the
location of the 2 short screws. See Figure 6.12. Remove lid and set aside.
Note: Early systems will have a piece of kapton tape over the bottom left screw hole with no screw
present. Later systems will have a spring screw installed in this location. The spring screw prevents the
shield from flexing and possibly damaging components on the Main PCBA near that corner and can
reduce the likelihood of assert codes due to this damage. If the Main PCBA is replaced, the Service
Assembly will come with the spring screw for installation on older systems mentioned above. There is no
need to proactively install this screw.

Power Supply
shield

Long Screws (7x)

Short Screws (2x)

Kapton
tape/spring
screw location

Figure 6.12 Power Supply Shield

2 Gently lift the Power Supply PCBA and Power Supply Shield away from the Main PCBA as shown in
Figure 6.13. (The Power Supply PCBA connector is in the upper left corner. Removing the Power
Supply PCBA without also removing the shield is difficult.)
3 Once disconnected from the Main PCBA, separate the Power Supply PCBA from the Power Supply
shield.
4 Install the new Power Supply PCBA by reversing steps 1-2 and tighten all screws to 5.5 inch lbs.

54 Chapter 6: Replacement Procedures

 Power Supply connector
underneath mates Power
Supply PCB to the Main
PCBA

Power Supply PCBA

Figure 6.13 Power Supply PCBA

SD Card Replacement
Note:
The SD card is not field replaceable as the encryption can only be set at the factory. Main PCBAs are
matched to their SD card and for this reason, cards are also not interchangeable between systems.

USB Extension PCB Assembly Replacement

Required Part
• P20987 USB Extension PCB Assembly
USB Extension PCB Assembly Removal
Note: Please proceed to the Main PCBA Replacement section as all the steps detailed to replace the
Main PCBA will require the removal of the USB Extension PCB Assembly.

Main PCBA Replacement

Note: If the Main PCBA is replaced, the Service Assembly will come with the spring screw and a new set
of thermal pads for installation on the midframe. Reference Figure 6.17. Locally sourced Kapton Tape will
also need to be installed. If the system already has the new thermal pad/kapton tape arrangement, the
replacement is not required.

Required Parts
• Main PCBA
• P20593-XX Service Assembly Main PCBA, SonoSite Edge II
• V20593-XX Vet Service Assembly Main PCBA, SonoSite Edge II
• P23581-XX Service Assembly Main PCBA, SonoSite Edge II non-RoHS
• V23581-XX Vet Service Assembly Main PCBA, SonoSite Edge II non-RoHS

Chapter 6: Replacement Procedures 55

 Note: Non-RoHS PCBA’s are not allowed for use in the repair of RoHS systems. However, RoHS versions
may be used in the repair of Non-RoHS systems.
Note: The replacement Main PCBA does not include the Transducer Nest Frame Assembly. These parts
must be transferred from the original Main PCBA. If new parts are required, please order the following
components to complete the Transducer Nest Frame Assembly.
• Nest Frame Assembly, M-Turbo (Compatible with SonoSite Edge II system):
• P07750 Nest Frame Assembly
• P00364 Connector, Interposer (8x)
• P03833 Shield, Perimeter, Short (2x)
• P03834 Shield, Perimeter, Long (2x)
• P00924 Screw, Shoulder, Thrust Plate (4x)
• P00353 Wear Plate
• P00646 Spring, Thrust Plate, .047 wire (4x)
• P08200 Socket Head Cap Screw, M2.5-.45x10mm (4x)
Note: Nest frame parts listed above were included on early production systems. Most later systems have
a nest frame assembly that looks different, but is backward compatible. This nest frame below comes as a
complete assembly under one part number and should be used to repair any system that already has this
style. Parts are not interchangeable between nest frame assembly types. See Table A.5 and Table A.6.
• P22603 Assembly, Interposer, Turbo System

Main PCBA Removal

1 Remove the Power Supply PCBA as described in the previous steps.
2 Disconnect the power cable to the Fan Assembly and remove the 2 screws mounting the Fan Assembly.
Refer to Figure 6.14.

Screws (2x)

Small Hole Large Hole (key)

Figure 6.14 Fan Assembly Screws

3 Remove the 5 screws holding the Main PCBA and the 2 screws holding the USB Extension PCB onto
the SonoSite Edge II Base. Refer to Figure 6.15.
4 Disconnect the speaker wires from the Main PCBA.
Caution:
Use caution when removing the left speaker connector to prevent damage to the Main PCBA components
around the connector.

56 Chapter 6: Replacement Procedures

 Screws (5x)

Screws (2x)

Figure 6.15 Main PCBA Screws

5 Turn the system over.

6 Remove the 4 Socket Head Cap Screws as shown in Figure 6.16. This releases the Nest Frame and
will allow the Main PCBA to be removed.
7 As you remove the nest frame assembly from the PCBA, tilt the PCBA and enclosure to almost vertical
to avoid spilling the Interposer Connectors from the assembly.
8 Lift on the edge of the Main PCBA closest to the system handle at the front right edge. Pull up from the
side where the Fan Assembly mounts.
9 Disconnect the USB Extension PCB Assembly from the Main PCBA.

2.5mm Socket Head Cap Screw

Screws (4x)

Figure 6.16 Nest Frame Top Screws

Main PCBA Replacement

1 Replace the Main PCBA by following the reverse of the removal procedure. Do not tighten all the screws
until everything is in place.Connect the USB Extension PCB Assembly to the Main PCBA.
2 Replace the Main PCBA.

Chapter 6: Replacement Procedures 57

 3 Reinstall the Fan Assembly.
4 Reinstall the Nest Frame Assembly. The Nest Frame Socket Head Cap Screws should be torqued to
4.5-inch pounds.
Caution:
The Nest Frame is keyed onto the Main PCBA via two smaller and two larger hole sizes. Installing
incorrectly (180 degrees out) will result in the SonoSite Edge II system being unable to recognize any
connected transducers. Refer to Figure 6.14.
5 Reconnect the speaker wires.
6 Reinstall the Power Supply PCBA.
7 Reinstall the Power Supply Shield.
8 Tighten all screws to their specified torque of 5.5-inch pounds.
9 Reinstall the Control Panel.
10 Reinstall the Top Enclosure Assembly.
11 Reinstall the Bottom Enclosure.

Midframe Replacement

Required Parts
• P20455 Midframe, SonoSite Edge II
• P15984 Gasket, EMI/ESD (2 Required)
• P07885 Thermal Pad, 1.00 x 1.00 x 0.100” (3 Required)
• P07886 Thermal Pad, 0.35 x 0.35 x 0.100” (12 Required)
• P14977 VHB, Magnet, MT+ (4 Required)
• P15742 Magnet, 1” x .25” x .25” THK (4 Required)
• Kapton Tape, 3M part # 5433 (sourced locally), 1.0 In wide, 1Mil, Linered, 1” x 1” piece, (5 required)
Midframe Replacement
Note: The EMI/ESD Gaskets and the Thermal Pads may be reused from the old assembly but we advise
using new items to ensure that these will contact the necessary areas properly.
1 Refer to Figure 6.17 for a view of the Midframeand thermal pad placement. Earlier systems had two-one
inch pads in the upper left corner which are now each replaced by four of the smaller pads. The Kapton
Tape prevents the pads from sticking to the components and allows for easier removal of the Main
PCBA..
2 Follow all the above procedures to remove all PCB assemblies and all the hardware fastened to the
original Midframe.
3 Transfer all the components to the new Midframe.
4 Finish assembly by reversing step 2.

58 Chapter 6: Replacement Procedures

 Figure 6.17 Midframe With Thermal Pads

Bottom Enclosure Replacement

Required Parts
Note: Contact SonoSite Technical Support if it is necessary to replace the bottom enclosure. Ordering the
bottom enclosure requires special handling due to the serial number label.

Chapter 6: Replacement Procedures 59

60 Chapter 6: Replacement Procedures
Chapter 7: Maintenance

This chapter contains information to help you properly care for the system, transducers, and accessories.

Periodic Maintenance
No periodic or preventive maintenance is required for the system, transducers, or accessories other than
cleaning and disinfecting the transducer after every use. For cleaning and disinfecting, please reference the
SonoSite Edge II User Guide. For a complete list of approved cleaners and disinfectants, please visitthe
support section of www.sonosite.com.
There are no internal adjustments or alignments required and there are no internal components that require
periodic testing, calibration, adjustment, or alignment. Performance tests are described in Chapter 8,
“Performance Testing” of this manual. Performing maintenance procedures not described in this manual
may void the product warranty.
Local regulations may require electrical safety testing.
Contact SonoSite Technical Support for any maintenance questions. (See “Contact Information”on page 1.)

Chapter 7: Maintenance 61
62 Chapter 7: Maintenance
Chapter 8: Performance Testing

Overview
WARNING: Critical Test Function — A failure of the system functions tested in this section could
adversely affect safety or effectiveness of the system. While performing the steps in this
section, verify that the images on the system display and on the external monitor are
acceptable.

To obtain 2D images, SonoSite recommends using the Gammex 403GS Soft Tissue Phantom or the
Gammex 413A Multipurpose Phantom. A .7db/cm phantom is recommend but not required.
Some features and capabilities are optional and therefore may be unavailable to test.

Recommend Test Equipment

• SonoSite ultrasound system under test
• rC60xi/5-2 MHz transducer
• rP19x/5-1 MHz transducer
• Gammex 403 GS Multipurpose Phantom, 413A Soft Tissue Phantom, or equivalent.
• Acoustic gel
• Edge Mini-Dock

Setting Up Performance Tests

Set up 1 Attach the rC60xi/5-2 MHz transducer to the system.

Performance 2 Select Gen for optimization and OB for exam type.
Tests 3 Couple the transducer to the phantom, adjusting gain settings and transducer for a
proper phantom image (e.g., pins are high-level echoes positioned in straight lines;
cysts are sonolucent, edges are sharp, and graphite particles of the phantom are
mid-grays).

Chapter 8: Performance Testing 63

Basic Operational Tests

Basic System 1 Verify that the correct transducer name appears in the upper right corner of the system
Operation display.
Tests 2 Verify proper date and time.
3 Verify that the scan plane orientation mark in the image located near the skinline
corresponds to element #1 on the transducer. To test, put your finger on the transducer
lens at the edge closest to the orientation bump on the transducer enclosure. Run your
finger across the transducer lens. Your finger touching the transducer lens should
appear at the orientation mark on the display image when your finger is near the
orientation bump on the transducer.
4 Verify that all of the touchscreen keyboard keys are functional. Verify that all touch
controls operate and that the system responds properly.
5 Verify that as the Gain controls are increased and decreased, there is a corresponding
increase and decrease in echo intensity.
6 Capture a Cineloop buffer. Exercise the Cineloop controls and verify proper operation.
7 Set the sleep and power delay settings and ensure they work properly.
8 Verify the airflow from the vent on the bottom of the system is blowing out.

2D Performance Tests

2D Performance / Image Quality

Test 2D 1 Use an rC60xi/5-2 MHz transducer in 2D mode.

Performance 2 Adjust the position of the rC60x/5-2 MHz transducer on the phantom.
and Image 3 With the array pointing down and the orientation mark to the operator’s left, element
Quality #1 corresponds with the left side of the array.
4 Use the 2D system controls to obtain a clear image that shows both the horizontal and
vertical rows of pins.
5 Verify that the ultrasound image appears uniform in both the axial and lateral direction,
with no dropouts or intensity variations.
6 Verify that the cystic structure at the focal zone is clearly differentiated from the
surrounding tissue and is echo-free, while solid tissue with numerous echo sources,
appears solid.
7 Tap the Freeze button and then save the image. Tap the Freeze button again to return
to live imaging.

64 Chapter 8: Performance Testing

Axial Measurement Accuracy
Note: Measurements must be performed while the image is frozen.

Set Up Axial 1 Acquire the image.

Measurement 2 Tap the Freeze button.
Accuracy 3 Tap Calipers. The calipers appear on the image display. (See the SonoSite Edge II
Ultrasound System User Guide, if necessary, for caliper operation.)
4 Use the touchpad or touchscreen to position the active caliper.
5 Select the other caliper in either of the following two methods.
• If using the touchpad, move the on-screen cursor to the other caliper and tap the
touchpad
• If using the touchscreen, tap on the other caliper
6 Use the touchpad or touchscreen to move the other caliper. The results update as you
move the caliper, and the measurement is complete when you finish moving the
calipers. Alternate between calipers by selecting on touchscreen or using the
touchpad to move the on-screen cursor.
Test Axial 1 Measure the distance, center to center, of any two pins that are 5-12 cm apart
Measurement vertically.
Accuracy 2 Verify that the distance measured is within the tolerance listed in Table 8.1.

Lateral Measurement Accuracy

Set Up Lateral Perform “Set Up Axial Measurement Accuracy” on page 65.

Measurement
Accuracy
Test Lateral 1 Measure the distance, center to center, of any two pins that are 4-10 cm apart
Measurement horizontally.
Accuracy 2 Verify that the distance measured is within the tolerance listed in Table 8.1.
3 Tap the Freeze button to return the system to live 2D mode.

Table 8.1: System Measurement Accuracy

Measurements Tolerance

Axial Distance +/- 2%

Lateral Distance +/- 2%

Chapter 8: Performance Testing 65

Penetration
The penetration measurement is an integral part of the quality assurance program. Penetration is defined
as the deepest depth at which an ultrasound system can provide adequate image quality of small
anatomical structures.
Penetration measurements should be performed and the results retained for comparison to future
measurements. Penetration measurements should remain fairly consistent over time assuming use of the
same system settings and scanhead. Degradation of the penetration measurement in excess of 1cm may
indicate a transducer or system electronics issue.
Loss of measured penetration may also be caused by degradation (dessication) of the ultrasound phantom.
Ultrasound phantoms used for penetration measurements must also be part of a quality assurance program
to maintain their integrity. Follow all of the phantom manufacturer recommendations for use, storage, and
maintenance of the phantom.

Test 1 Use the same scanhead and system settings as previous measurements if possible.
Penetration 2 Adjust the system controls to obtain a clear image that shows the limits of echo
penetration.
3 Tap the Freeze button and then save the image.
4 Measure from the center of the skinline to the deepest vertical position—where the
scatter echoes start to break up and tissue definition is lost.
5 Record and retain the results for future reference. Scanhead type and system settings
(exam type, depth, resolution mode, etc.) should also be recorded to ensure proper
comparison with future tests.
6 Tap the Freeze button again to return to live imaging.

Additional Performance Tests

Color Doppler (Color)

Test Color 1 Connect any transducer.

2 Tap the Color button. “Color” should be annotated in the top left corner of the display.
3 A Region of Interest (ROI) box is displayed on top of the grayscale image. Use the
touchpad to move the Color ROI. Verify that the ROI moves to the new position on the
display.
4 Adjust the Depth control for minimum depth in the image.
5 Adjust the Gain control so that color speckles just appear inside the ROI box.
6 Gently tap the face of the transducer and observe that the ROI box fills with color
information.
7 Tap the Freeze button and then save the image. Tap the Freeze button again to return
to live imaging.

66 Chapter 8: Performance Testing

Color Power Doppler (CPD)

Test CPD 1 Connect any transducer.

2 Tap the Color button. A Region of Interest (ROI) box is displayed on top of the
grayscale image.
3 Tap the Color button to switch to CPD. “CPD” should be annotated in the top left
corner of the display.
4 Adjust the Depth control for minimum depth in the image.
5 Adjust the Gain control so that color speckles just appear inside the ROI box.
6 Gently tap the face of the transducer and observe that the ROI box fills with color
information.

M Mode Imaging

Test M Mode 1 Attach an rC60xi transducer and acquire an image.

Imaging 2 Tap the M Mode button for the M Mode sample line.
3 Position the M Mode sample line over the image using the touchpad.
4 Tap the M Mode button again to turn on M Mode.
5 Select the desired sweep speed from the on-screen menu (slow, med, or fast). The
on-screen menu will show the selected sweep speed.
6 Tap the Freeze button to freeze the image. Save the image. Tap the Freeze button
again to return to live imaging.
7 Tap the 2D button to return to 2D imaging.

Tissue Harmonic Imaging

Test THI 1 Attach the rC60xi transducer and acquire an image.

Imaging 2 Set the depth to maximum and note the depth at which echo information is lost.
3 Tap the THI button on the screen controls so it displays THI in the mode area. Tissue
Harmonic Imaging in now active.
4 Observe a decrease in dot size and a significant loss in penetration due to the higher
frequency. Image resolution increases.
5 Tap the Freeze button and then save the image. Tap the Freeze button again to return
to live imaging.
6 Tap the THI button again to turn off Tissue Harmonic Imaging.

Image Quality Verification Test/Livescan

• Products with replaced subassemblies, or products that have been otherwise disassembled, must
undergo an Image Quality Verification Test/Livescan.
• The Image Quality Verification Test/Livescan should be performed after successfully completing all
applicable performance tests listed prior in this chapter.
• The test is completed before returning the system to service.
• A certified sonographer must perform the test.
• The Livescan test performed is at the discretion of the Sonographer and will represent their acceptance
of a successful service event.
• Review all saved images and verify that the images are displayed properly.

Chapter 8: Performance Testing 67

Printer
The printer test is an optional test that requires a video printer and Mini-Dock to be connected to the system
under test. Skip this test if a printer is not available.

Test Printer 1 Connect the Mini-Dock to the system under test.

Operation 2 Connect a video output and print control cable from theMini-Dock to the printer.
3 Verify proper printer type is configured in the system Settings page.
4 Tap the print button and verify that the printer begins to print an image. After the image
begins to emerge from the printer, tap the print button again. The printer should ignore
the second print command.
5 Verify the proper content of the printed image.

Battery Charging

Test Battery 1 Remove the AC power cord and insert a battery into the system.
Charging 2 Press the Power button to turn the system on. Allow the battery to discharge. The
Operation battery indicator icon on the display, below the Transducer Type indicator, will
extinguish from right to left as the battery discharges.
Note: The Power and Sleep delays in the Setup page should be selected to “Off” to
properly perform this test. The battery may take 1–2 hours to discharge.
3 Reattach the AC power cord to the power connector and power the system on.
4 Note that the battery indicator indicates that the battery is charging. The sections of
the battery indicator will light sequentially from left to right as the battery charges.

Video Output
The video output test is an optional test that requires an external video monitor to be connected to the
system under test. Skip this test if an external monitor is not available.

Test Video 1 Connect the Mini-Dock to the system under test.

Output 2 Connect the video output on the Mini-Dock to an external video monitor.
3 Turn on the system power and verify that the video on the external monitor matches
the video on the system display.
If the video does not appear similar, or there is no display on the external monitor, see
Chapter 5, “Troubleshooting” for troubleshooting procedures.

68 Chapter 8: Performance Testing

Appendix A: Replacement Parts

Replacement Parts
The following tables contain all the field-replaceable parts for the SonoSite Edge II ultrasound system.
Quantities are one unless otherwise noted.

Display

Table A.1: Display

Part Number Description

P21147-XX Service Assembly, Display, SonoSite Edge II

V21147-XX Vet Service Assembly, Display, SonoSite Edge II

Appendix A: Replacement Parts 69

Control Panel

Table A.2: Control Panel

Part Number Description

P21581-XX Service Assembly Control Panel, English, SonoSite Edge II

V21581-XX Vet Service Assembly Control Panel, English, SonoSite Edge II

P21582-XX Service Assembly Control Panel, French, SonoSite Edge II

V21582-XX Vet Service Assembly Control Panel, French, SonoSite Edge II

P21583-XX Service Assembly Control Panel, German, SonoSite Edge II

V21583-XX Vet Service Assembly Control Panel, German, SonoSite Edge II

P21584-XX Service Assembly Control Panel, Spanish, SonoSite Edge II

V21584-XX Vet Service Assembly Control Panel, Spanish, SonoSite Edge II

P21585-XX Service Assembly Control Panel, Italian, SonoSite Edge II

V21585XX Vet Service Assembly Control Panel, Italian, SonoSite Edge II

P21586-XX Service Assembly Control Panel, Portuguese, SonoSite Edge II

V21586-XX Vet Service Assembly Control Panel, Portuguese, SonoSite Edge II

70 Appendix A: Replacement Parts

Main PCBA

3 2

Table A.3: Main PCBA

Item Part Number Description

1 P20593-XX Service Assembly, Main PCBA, SonoSite Edge II

V20593-XX Vet Service Assembly, Main PCBA, SonoSite Edge II
P23581-XX Service Assembly, Main PCBA, Edge II, Non-RoHS (for system PN
P23610-XX)
V23581-XX Vet Service Assembly, Main PCBA, Edge II, Non-RoHS (for system PN
V23610-XX)
Note: Non_RoHS parts are not allowed for use in repair of RoHS
systems. However, RoHS versions may be used in the repair of
Non-RoHS systems.
Note: This part does not include the transducer nest frame assembly.
Those parts must be ordered separately if needed to complete the
replacement of the Main PCBA.

2 P19909-XX Service Assembly, Power Supply, M-Turbo, Edge (compatible with

Sonosite EII system).
V19909-XX Vet Service Assembly, Power Supply, M-Turbo, Edge (compatible with
SonoSite EII system).

3 P09541 Power Supply Shield

Appendix A: Replacement Parts 71

Table A.3: Main PCBA (Continued)

Item Part Number Description

4 *P22955 16GB MicroSD Card (Resides on Main PCBA under shield). Part of
Memory Assembly, P22956 which also includes MicroSD to SD Card
Adapter, P21076.
*This item is not field replaceable. The SD card is joined with the Main
PCBA through the encryption key which is programmed at the factory.
SD card failure will require return of the system to the factory for repair.
If the Main PCBA is replaced in the field, the SD card that comes with
the Main PCBA must be used. The card from the old PCBA will not
work with the new PCBA.

Not shown P09542 Power Supply Shield Cover. Attaches to Item 3 Power Supply Shield

72 Appendix A: Replacement Parts

Miscellaneous Parts
Table A.4: Miscellaneous Parts

Part Number Description

Cables (images are not to scale)

P02308 FFC, 12 Position Jumper, 0.5 Pitch, 3” Length (3” Flat Flex Cable)

This cable is used on the Control Panel PCB and Main PCBA to TGC
connection.

P14729 Cable Assy, Main to Control Panel PCB, Video

P14747 Cable, Main To Control Panel PCB, Backlight

P17102 TGC PCB Assembly

P20458 Lower Gain Knob

P20668 Upper Gain Knob

Appendix A: Replacement Parts 73

Table A.4: Miscellaneous Parts

Part Number Description

Other Electrical Parts

P21619 Dual Fan Assembly

P03872 Speaker Assembly

P20987 USB Extension PCB Assy

P14742 Compression Connector Insulator, EDGE (Used with P15273)

P15273 Connector, Compression 166 Wires/Inch, 33.350 (Used with P14742)

74 Appendix A: Replacement Parts

Table A.4: Miscellaneous Parts

Part Number Description

Mechanical/Cosmetic Parts

P16121 Bottom Enclosure

Contact SonoSite Technical Support if it is necessary to replace the

bottom enclosure. Ordering the bottom enclosure requires special
handling due to the serial number label.

P09542 Power Supply Shield

Appendix A: Replacement Parts 75

Table A.4: Miscellaneous Parts

Part Number Description

P14750 Foot (4x)

P21783 Hinge Cover

P20455 Midframe

P23384 Service Assembly, Screw, Spring, 0100S. Includes Screw, P23251 and
Spring, P23381

76 Appendix A: Replacement Parts

Transducer Nest Frame Assembly
7

2 6
5

3
4

Figure A.1 Nest Frame Parts

Table A.5: Nest Frame Assembly

Find
Part Number Description
Number

1 P07750 Nest Frame Assembly

2 P00364 Connector, Interposer (8x)

3 P03833 Shield, Perimeter, Short (2x)

4 P03834 Shield, Perimeter, Long (2x)

5 P00924 Screw, Shoulder, Thrust Plate (4x)

6 P00353 Wear Plate

not shown P00646 Spring, Thrust Plate, .047 wire (4x)

7 P08200 Socket Head Cap Screw, M2.5-.45x10mm (4x)

Note: A new version of the Nest Frame assembly is available and backwards compatible with early
systems. Parts are not interchangeable between assemblies.

3 6

7
4
8
5

Appendix A: Replacement Parts 77

 Figure A.2 New nest frame parts

Table A.6: Assembly, Interposer, Turbo System

Find
Part Number Description
Number

1 P22603 Assembly, Interposer, Turbo System

2 P22545 Frame, Nest, Interposer, Turbo System

3 P21532 Connector, Interposer (8x)

4 P21527 Shield, Perimeter, Short (2x)

5 P21523 Shield, Perimeter, Long (2x)

not shown P21529 Screw, Shoulder, Thrust Plate (4x)

6 P21531 Wear Plate, Turbo

not shown P21529 Spring, Wear Plate (4x)

not shown P08200 Socket Head Cap Screw, M2.5-.45x10mm (4x)

7 P21537 Guard, Perimeter Shield, Turbo

8 P22538 Screw, Perimeter Shield, X-Porte $ FC1, Spring Loaded

not shown P22528 Spring, Perimeter Shield, X-Porte & FC1

Ordering Replacement Parts

To order parts, contact SonoSite Technical Support as indicated in “Contact Information”on page 1.

78 Appendix A: Replacement Parts

Appendix B: Service Event Reporting

The Service Event Report provides information about product failures to the manufacturer and to authorized
service facilities, which provide approved warranty services for SonoSite products. For all repairs
completed, complete the form and email a copy of it to [email protected] or mail to the following
address:
Fujifilm SonoSite, Inc.
Technical Support
21919 30th Drive SE
Bothell, Washington 98021
USA

To contact SonoSite Technical Support, see“Contact Information” on page 1.

Appendix B: Service Event Reporting 79

Service Event Report Form

Service Event Report

Instructions on reverse

Service Type (check one) Parts Status (check one) For FUJIFILM SonoSite Use Only
No parts necessary for this repair. Service
† Out of Box Failure † Event Report for your information. Service Request
I need parts for this repair (list the parts below
† Warranty Service † and attach Purchase Order) Order Number
I need parts to replenish my stock (list the
† Out of Warranty Service † parts used below and attach Purchase Order) RMA Number
Will not replenish stock. Please give me a
† RMA for the return of the faulty parts. Work Order
No parts necessary. Please issue a RMA for
† repair at FUJIFILM SonoSite.

Service Provider
Name: Provider Reference:
Company: Date Reported:
Address:
Phone Number: Fax Number:
E-mail address:

Device Description
Ref Number: Serial Number:
Name: Lot Number:
ARM/SHDB Version: Configuration:

Problem Found

Service Performed

Performed By: Date:

Parts Removed
Part Name Part Number Serial Number Lot Number Rev Replaced By

Parts Installed
Part Name Part Number Serial Number Lot Number Rev Replaced By

Tests Performed (attach test data)

Test: Test:
Performed By: Performed By:
Result: Pass Fail Result: Pass Fail
Attach additional sheets as required
Page ____ of ____ F00019 Rev F

80 Appendix B: Service Event Reporting

Service Event Report Instructions

Instructions for completing the Service Event Report

Sections highlighted in yellow must be completed for SonoSite to accept the Service Event Report. If additional information is
required for certain circumstances you will be advised.
Forward the completed form to:
Email: [email protected]
Fax: +1-425-951-6700
Service Type
x Out of Box Failure: the item has arrived from SonoSite with failures.
x Warranty Service: the item has failed after arrival and is covered by either the included warranty or a valid extended
warranty.
x Out of Warranty Service: the item has failed and it is no longer covered by a warranty.

Parts Status
x Check One.

Service Provider
x Name: the name of the technician performing the work.
x Provider Reference: a unique number used by the Provider to track Service Event Reports. Any format is acceptable.
x Company: the name of the Distributor or authorized repair facility.
x Address: the address replacement parts will be shipped to.
x Date Reported: the date the failure was reported to SonoSite.
x Phone Number: the phone number to contact the service technician.
x Fax Number: the fax number to contact the service technician.
x Email Address: the email address to contact the service technician.

Device Description:
x Name: the description of the failed product.
x Ref Number: the reference number from the part number label of the failed product.
x Serial Number: the serial number from the part number label of the failed product.
x Lot Number: if applicable, the Lot Number from the device identification label.
x ARM/SHDB Version: the software level of the failed device. Typically found on the system information screen.
x Configuration: for configurable devices, the optional features enabled.

Event Description
x A description of the problem in the words of the user. Typically what the user reports to the repair facility.

Diagnosis
x A description of what the repair technician found. Include a list of the suspect parts.

Service Performed
x A description of the work performed to repair the system. Typically only completed if it is repaired from stock repair parts.

Parts Removed
x Part Name: the name of the failed/suspect part to be replaced.
x Part Number: the part number of the failed/suspect part.
x Serial Number: the serial number from the failed/suspect part.
x Lot Number: the lot number if applicable.
x Rev: the revision of the failed/suspect part if available.
x Replaced By: the person replacing the part.

Parts Installed
x The same information as the Parts Removed except from the parts installed if work has already been performed. If you are
waiting for parts to be ordered, leave this section blank.

Tests Performed
x The results of any testing performed, if testing has already been performed.

Appendix B: Service Event Reporting 81

Returning Products to SonoSite
You will be asked to provide the following information:
• Contact name and phone number
• Product name
• Serial number
• Description of the problem

Shipping Instructions
Please contact SonoSite to get a return material authorization number (RMA). Contact SonoSite before
returning any product.
The shipping address for all returned products is:
FujiFilm SonoSite, Inc.
Attn: Technical Support RMA ___________________
21919 30th Drive SE
Bothell, Washington 98021
USA

82 Appendix B: Service Event Reporting

Numerics
2D performance tests
axial measurement accuracy 65
image quality 65
lateral measurement accuracy 65
penetration 66
A
ALARA 15
assert code 40
assistance, customer 1
B
battery
safety 14
specifications 8
battery charging test 68
biological safety 15
bottom enclosure replacement 60
C
cautions, definition 2
Control 43, 49, 51
control panel subassembly replacement 49
D
DICOM 42
Display 43
display removal 45
display replacement 45, 49
E
electrical
safety 11
specifications 7
electromagnetic compatibility 16
equipment safety 13
error message 12
F
Failure Reporting 79
H
humidity limits 7
I
image
quality verification test 67
review 68
Introduction 1

83
M
Main 58
main PCBA
failures 40
main system disassembly 51
Midframe 60
Midframe Replacement 59
P
performance tests
2D 64
battery 68
CPD 67
CW 67
M-Mode 67
overview 63
printer 68
PW 67
THI 67
Velocity Color 66
video output 68
periodic maintenance 61
Power 39
power supply PCBA replacement 55
Power-0 Reset 39
pressure limits 7
printer
test 68
Product Failures 79
R
replacement parts
list 69
ordering 78
Return Material Authorization number (RMA) 82
Returning Products 82
S
safety
battery 14
biological 15
electrical 11
electromagnetic compatibility 16
equipment 13
SD card daughter-card replacement 56
Service 76
Service Event Report 79
Shipping Instructions 82
shipping specifications 7

84
speaker replacement 53
storage specifications
equipment 7
subassembly replacement 39
System 53
system
measurement accuracy 65
overview 23
T
temperature limits 7
theory of operation 24
U
USB extension PCB replacement 56
user guide, conventions used 2
V
video output tests 68
W
warnings, definition 2

85
86
87
 P21828-02
*P21828-02*

88